Clonidine Hydrochloride Tablets, USP

0.05 mg • 60ct Bottle
0.05 mg
60ct Bottle
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NOW AVAILABLE FROM ALEMBIC THERAPEUTICS

Clonidine Hydrochloride Tablets, USP

Product Name:
Clonidine Hydrochloride Tablets, USP
Strength:
0.05 mg
Package Size:
60ct Bottle
NDC:
62332-169-60
Dosage Form:
Oral Tablet (Rx only)

Important Safety Information (ISI)

Clonidine Hydrochloride Tablets, USP 0.05 mg
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INDICATION AND USAGE

Clonidine hydrochloride tablets USP are indicated in the treatment of hypertension. Clonidine hydrochloride may be employed alone or concomitantly with other antihypertensive agents.

CONTRAINDICATIONS

Clonidine hydrochloride tablets USP should not be used in patients with known hypersensitivity to clonidine.

WARNINGS: WITHDRAWAL

Patients should be instructed not to discontinue therapy without consulting their physician. Sudden cessation of clonidine treatment has, in some cases, resulted in symptoms such as nervousness, agitation, headache, and tremor accompanied or followed by a rapid rise in blood pressure and elevated catecholamine concentrations in the plasma.

ADVERSE REACTIONS

Most adverse effects are mild and tend to diminish with continued therapy.

The most frequent (which appear to be dose-related) are dry mouth, occurring in about 40 of 100 patients; drowsiness, about 33 in 100; dizziness, about 16 in 100; constipation and sedation, each about 10 in 100.

The following less frequent adverse experiences have also been reported in patients receiving clonidine hydrochloride, but in many cases patients were receiving concomitant medication and a causal relationship has not been established.

INFORMATION FOR PATIENTS
  • Patients should be cautioned against interruption of clonidine hydrochloride therapy without their physician's advice.
  • Since patients may experience a possible sedative effect, dizziness, or accommodation disorder with use of clonidine, caution patients about engaging in activities such as driving a vehicle or operating appliances or machinery. Also, inform patients that this sedative effect may be increased by concomitant use of alcohol, barbiturates, or other sedating drugs.
  • Patients who wear contact lenses should be cautioned that treatment with clonidine hydrochloride may cause dryness of eyes.
Medical Inquiries & Adverse Event Reporting

To report SUSPECTED ADVERSE REACTIONS or side effects, contact Alembic Therapeutics LLC at
1-866-210-9797 or the FDA at 1-800-FDA-1088 or visit www.fda.gov/medwatch.

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