Prescription Drug Information: Clonidine Hydrochloride (Page 2 of 2)

Nursing Mothers

As clonidine hydrochloride is excreted in human milk, caution should be exercised when clonidine hydrochloride tablets USP are administered to a nursing woman.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established in adequate and well-controlled trials (see WARNINGS, Withdrawal).

Adverse Reactions to Clonidine Hydrochloride

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 tablets USP, but in many cases patients were receiving concomitant medication and a causal relationship has not been established.

Body as a Whole: Fatigue, fever, headache, pallor, weakness, and withdrawal syndrome. Also reported were a weakly positive Coombs’ test and increased sensitivity to alcohol.

Cardiovascular: Bradycardia, congestive heart failure, electrocardiographic abnormalities (i.e., sinus node arrest, junctional bradycardia, high degree AV block and arrhythmias), orthostatic symptoms, palpitations, Raynaud’s phenomenon, syncope, and tachycardia. Cases of sinus bradycardia and atrioventricular block have been reported, both with and without the use of concomitant digitalis.

Central Nervous System: Agitation, anxiety, delirium, delusional perception, hallucinations (including visual and auditory), insomnia, mental depression, nervousness, other behavioral changes, paresthesia, restlessness, sleep disorder, and vivid dreams or nightmares.

Dermatological: Alopecia, angioneurotic edema, hives, pruritus, rash, and urticaria.

Gastrointestinal: Abdominal pain, anorexia, constipation, hepatitis, malaise, mild transient abnormalities in liver function tests, nausea, parotitis, pseudo-obstruction (including colonic pseudo-obstruction), salivary gland pain, and vomiting.

Genitourinary: Decreased sexual activity, difficulty in micturition, erectile dysfunction, loss of libido, nocturia, and urinary retention.

Hematologic: Thrombocytopenia.

Metabolic: Gynecomastia, transient elevation of blood glucose or serum creatine phosphokinase, and weight gain.

Musculoskeletal: Leg cramps and muscle or joint pain.

Oro-otolaryngeal: Dryness of the nasal mucosa.

Ophthalmological: Accommodation disorder, blurred vision, burning of the eyes, decreased lacrimation, and dryness of eyes.

OVERDOSAGE


Hypertension may develop early and may be followed by hypotension, bradycardia, respiratory depression, hypothermia, drowsiness, decreased or absent reflexes, weakness, irritability and miosis. The frequency of CNS depression may be higher in children than adults. Large overdoses may result in reversible cardiac conduction defects or dysrhythmias, apnea, coma and seizures. Signs and symptoms of overdose generally occur within 30 minutes to two hours after exposure. As little as 0.1 mg of clonidine has produced signs of toxicity in children.

There is no specific antidote for clonidine overdosage. Clonidine overdosage may result in the rapid development of CNS depression; therefore, induction of vomiting with ipecac syrup is not recommended. Gastric lavage may be indicated following recent and/or large ingestions. Administration of activated charcoal and/or a cathartic may be beneficial. Supportive care may include atropine sulfate for bradycardia, intravenous fluids and/or vasopressor agents for hypotension and vasodilators for hypertension. Naloxone may be a useful adjunct for the management of clonidine-induced respiratory depression, hypotension and/or coma; blood pressure should be monitored since the administration of naloxone has occasionally resulted in paradoxical hypertension. Tolazoline administration has yielded inconsistent results and is not recommended as first-line therapy. Dialysis is not likely to significantly enhance the elimination of clonidine.

The largest overdose reported to date involved a 28-year old male who ingested 100 mg of clonidine hydrochloride powder. This patient developed hypertension followed by hypotension, bradycardia, apnea, hallucinations, semicoma, and premature ventricular contractions. The patient fully recovered after intensive treatment. Plasma clonidine levels were 60 ng/ml after 1 hour, 190 ng/ml after 1.5 hours, 370 ng/ml after 2 hours, and 120 ng/ml after 5.5 and 6.5 hours. In mice and rats, the oral LD50 of clonidine is 206 and 465 mg/kg, respectively.

DOSAGE AND ADMINISTRATION

Adults

The dose of clonidine hydrochloride tablets USP must be adjusted according to the patient’s individual blood pressure response. The following is a general guide to its administration.

Initial Dose

0.1 mg tablet twice daily (morning and bedtime). Elderly patients may benefit from a lower initial dose.

Maintenance Dose

Further increments of 0.1 mg per day may be made at weekly intervals if necessary until the desired response is achieved. Taking the larger portion of the oral daily dose at bedtime may minimize transient adjustment effects of dry mouth and drowsiness. The therapeutic doses most commonly employed have ranged from 0.2 mg to 0.6 mg per day given in divided doses. Studies have indicated that 2.4 mg is the maximum effective daily dose, but doses as high as this have rarely been employed.

Renal Impairment

Patients with renal impairment may benefit from a lower initial dose. Patients should be carefully monitored. Since only a minimal amount of clonidine is removed during routine hemodialysis, there is no need to give supplemental clonidine following dialysis.

HOW SUPPLIED

Clonidine hydrochloride tablets USP are supplied as follows:

Clonidine hydrochloride tablets USP 0.1 mg, yellow, round, debossed MP 657 on one side and plain on the other side.

Bottles of 100 NDC 52817-180-10
Bottles of 500 NDC 52817-180-50
Bottles of 1000 NDC 52817-180-00

Clonidine hydrochloride tablets USP 0.2 mg, white, round, debossed MP 658 on one side and plain on the other side.

Bottles of 100 NDC 52817-181-10
Bottles of 500 NDC 52817-181-50
Bottles of 1000 NDC 52817-181-00

Clonidine hydrochloride tablets USP 0.3 mg, green, round, debossed MP 659 on one side and plain on the other side.

Bottles of 100 NDC 52817-182-10
Bottles of 500 NDC 52817-182-50
Bottles of 1000 NDC 52817-182-00

Store at 20° to 25°C (68° to 77°F).

[See USP Controlled Room Temperature]

DISPENSE IN TIGHT, LIGHT-RESISTANT CONTAINER.

Add ress medical inquiries to: 1-877-541-5504 .

Manufactured by: Frontida BioPharm, Inc

Philadelphia, PA 19124

Distributed by: TruPharma, LLC

Tampa, FL 33609

Rev00, March 2017

PRINCIPAL DISPLAY PANEL

NDC 52817-180 -10
Clonidine
Hydrochloride
Tablets, USP
0.1 mg
Rx Only 100 Tablets

PRINCIPAL DISPLAY PANEL
NDC 52817-180-10
Clonidine
Hydrochloride
Tablets, USP
0.1 mg
Rx Only
100 Tablets
(click image for full-size original)

PRINCIPAL DISPLAY PANEL

NDC 52817-180 -00
Clonidine
Hydrochloride
Tablets, USP
0.1 mg
Rx Only 1000 Tablets

PRINCIPAL DISPLAY PANEL
NDC 52817-180-00
Clonidine
Hydrochloride
Tablets, USP
0.1 mg
Rx Only
1000 Tablets
(click image for full-size original)

PRINCIPAL DISPLAY PANEL

NDC 52817-18 1 -10
Clonidine
Hydrochloride
Tablets, USP
0.2 mg
Rx Only 100 Tablets

PRINCIPAL DISPLAY PANEL
NDC 52817-181-10
Clonidine
Hydrochloride
Tablets, USP
0.2 mg
Rx Only
100 Tablets
(click image for full-size original)

PRINCIPAL DISPLAY PANEL

NDC 52817-18 1 -00
Clonidine
Hydrochloride
Tablets, USP
0.2 mg
Rx Only 10 0 0 Tablets

PRINCIPAL DISPLAY PANEL
NDC 52817-181-00
Clonidine
Hydrochloride
Tablets, USP
0.2 mg
Rx Only
1000 Tablets
(click image for full-size original)

PRINCIPAL DISPLAY PANEL

NDC 52817-182 -10
Clonidine
Hydrochloride
Tablets, USP
0.3 mg
Rx Only 100 Tablets

PRINCIPAL DISPLAY PANEL
NDC 52817-182-10
Clonidine
Hydrochloride
Tablets, USP
0.3 mg
Rx Only
100 Tablets
(click image for full-size original)

PRINCIPAL DISPLAY PANEL

NDC 52817-182 -00
Clonidine
Hydrochloride
Tablets, USP
0.3 mg
Rx Only 10 0 0 Tablets

PRINCIPAL DISPLAY PANEL
NDC 52817-182-00
Clonidine
Hydrochloride
Tablets, USP
0.3 mg
Rx Only
1000 Tablets
(click image for full-size original)
CLONIDINE HYDROCHLORIDE clonidine hydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:52817-180
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CLONIDINE HYDROCHLORIDE (CLONIDINE) CLONIDINE HYDROCHLORIDE 0.1 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE, UNSPECIFIED FORM
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
STARCH, CORN
SODIUM STARCH GLYCOLATE TYPE A POTATO
D&C YELLOW NO. 10
Product Characteristics
Color YELLOW Score no score
Shape ROUND Size 7mm
Flavor Imprint Code MP;657
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:52817-180-10 100 TABLET in 1 BOTTLE None
2 NDC:52817-180-50 500 TABLET in 1 BOTTLE None
3 NDC:52817-180-00 1000 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA070925 06/01/2017
CLONIDINE HYDROCHLORIDE clonidine hydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:52817-181
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CLONIDINE HYDROCHLORIDE (CLONIDINE) CLONIDINE HYDROCHLORIDE 0.2 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE, UNSPECIFIED FORM
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
STARCH, CORN
SODIUM STARCH GLYCOLATE TYPE A POTATO
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 7mm
Flavor Imprint Code MP;658
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:52817-181-10 100 TABLET in 1 BOTTLE None
2 NDC:52817-181-50 500 TABLET in 1 BOTTLE None
3 NDC:52817-181-00 1000 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA070924 06/01/2017
CLONIDINE HYDROCHLORIDE clonidine hydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:52817-182
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CLONIDINE HYDROCHLORIDE (CLONIDINE) CLONIDINE HYDROCHLORIDE 0.3 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE, UNSPECIFIED FORM
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
STARCH, CORN
SODIUM STARCH GLYCOLATE TYPE A POTATO
D&C YELLOW NO. 10
FD&C BLUE NO. 1
ALUMINUM OXIDE
Product Characteristics
Color GREEN Score no score
Shape ROUND Size 7mm
Flavor Imprint Code MP;659
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:52817-182-10 100 TABLET in 1 BOTTLE None
2 NDC:52817-182-50 500 TABLET in 1 BOTTLE None
3 NDC:52817-182-00 1000 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA070923 06/01/2017
Labeler — TruPharma, LLC (078533947)

Revised: 01/2020 TruPharma, LLC

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