Approved Drug Label (PDF)
Boxed Warning
PLR conversion;
revised as below:
WARNING: SEVERE
BRONCHOCONSTRICTION
Severe
bronchoconstriction can result from Provocholine administration (including the
lowest dose). The use of Provocholine is contraindicated in pediatric and adult
patients with baseline FEV1 <60% predicted or adults with FEV1 <1.5 L.
Because of the potential for severe bronchoconstriction, the use of
Provocholine in patients with clinically apparent asthma or wheezing is not
recommended.
Emergency
equipment and medication should be immediately available to treat acute
respiratory distress. If severe bronchoconstriction occurs, reverse immediately
with a rapid- acting inhaled bronchodilator agent (?-agonist).
If baseline
spirometry is not performed or measured inaccurately, the initial FEV1 may be
underestimated. In this situation, decreases in FEV1 may not be detected after
administration of escalating Provocholine doses, which may result in
administration of unnecessary higher doses and an increased risk for excessive
bronchoconstriction.
4
Contraindications
PLR conversion;
additions and/or revisions underlined:
Provocholine
is contraindicated in the following situations:
Hypersensitivity
to methacholine or other parasympathomimetic agents. Reactions have
included rash, itching/swelling (especially of the face/tongue/throat), severe
dizziness, trouble breathing.
Baseline FEV1 <60% predicted (adults or pediatric
patients) or <1.5 L (adults)
5
Warnings and Precautions
PLR conversion;
subsection titles as below (see label for complete information):
5.1 Risk of Severe
Bronchoconstriction
5.2 Risks to
Healthcare Providers Administering Provocholine
5.3 Coexisting Diseases and Conditions
6
Adverse Reactions
PLR conversion; as
below:
The
following adverse reactions associated with the use of Provocholine were
identified in clinical studies or postmarketing reports. Because some of these
reactions were reported voluntarily from a population of uncertain size, it is
not always possible to reliably estimate their frequency or establish a causal
relationship to drug exposure.
Bronchospasm
(includes symptoms such as chest tightness, cough or wheezing).
Adverse
reactions less commonly associated with Provocholine were include headache,
throat irritation, light-headedness and itching.
7
Drug Interactions
PLR conversion;
newly added information, as below:
Beta-Adrenergic
Blockers
The
use of beta-adrenergic blockers may impair reversal of Provocholine-caused
bronchoconstriction.
Beta-Agonists,
Anticholinergics, and Theophylline
Beta-agonists,
anticholinergics, and theophylline inhibit the response of airways to
Provocholine; therefore, hold these drugs before Provocholine use for the
following duration:
Short-acting
?-agonists (e.g., albuterol): 6 hours
Long-acting
?-agonists (e.g., salmeterol): 36 hours
Short-acting
anti-cholinergics (e.g., ipratropium): 12 hours
Long-acting
anti-cholinergics (e.g., tiotropium): greater than or equal to 168 hours
- Oral
theophylline: 12-48 hours
Oral or Inhaled Corticosteroids, and
Inhaled Cromyoglycate
Regular
use of oral or inhaled corticosteroids and inhaled cromoglycate may acutely
decrease bronchial responsiveness to Provocholine. However, these drugs may be continued with
Provocholine use.
8
Use in Specific Populations
8.1 Pregnancy
PLLR conversion;
as below:
Risk
Summary
The
available data from published literature on Provocholine use in pregnant women
are insufficient to evaluate for a drug-associated risk of major birth defects,
miscarriage, or adverse maternal or fetal outcomes. Animal reproduction studies
evaluating effects of methacholine chloride on embryofetal development have not
been conducted. Diagnosis of bronchial airway hyperreactivity with bronchoprovocation
challenge is not recommended for pregnant women because of the potential for
hypoxia. If bronchial airway
hyperactivity is suspected, consider trial of empiric treatment.
The
estimated background risk of major birth defects and miscarriage for the indicated
population is unknown. All pregnancies have a background risk of birth defect,
loss, or other adverse outcomes. In the United States general population, the
estimated background risk of major birth defects and miscarriage in clinically
recognized pregnancies is 2 to 4% and 15 to 20%, respectively.
8.2 Lactation
PLLR conversion;
as below:
Risk Summary
There
are no available data on the presence of methacholine chloride in human milk,
the effect on the breastfed infants, or the effect on milk production. The
developmental and health benefits of breastfeeding should be considered along
with the mother’s clinical need for Provocholine and any potential adverse
effects on the breastfed infant from Provocholine or from the underlying
maternal condition.
8.4 Pediatric Use
PLR conversion;
additions and/or revisions underlined:
Provocholine
is indicated for the diagnosis of bronchial airway hyperreactivity
(methacholine challenge test) in pediatric patients 5 years of age and older
who do not have clinically apparent asthma. The safety and effectiveness of
Provocholine have not been established in pediatric patients below the age of 5
years.
8.5 Geriatric Use
PLR conversion;
newly added subsection:
The
diagnosis of bronchial airway hyperreactivity is largely performed in pediatric
and younger adult patients. Clinical
studies of Provocholine did not include patients 65 years of age or older.
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
PATIENT COUNSELING INFORMATION
PLR conversion;
newly added section:
Risk
of Severe Bronchoconstriction
Inform
the patient or caregiver that severe bronchoconstriction can result from the
Provocholine administration.
Cough,
Chest Tightness, or Shortness of Breath
Inform
the patient or caregiver that Provocholine may produce mild cough, chest
tightness or shortness of breath.
Other
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