Clonidine Hydrochloride .1 mg/1
Clonidine Hydrochloride · TABLET · Bryant Ranch Prepack
Clonidine Hydrochloride is a tablet containing clonidine hydrochloride at .1 mg/1, taken oral. Manufactured by Bryant Ranch Prepack.
Key Facts
- Brand Name
- Clonidine Hydrochloride
- Generic Name
- Clonidine Hydrochloride
- NDC Code (Product)
72162-2609- Manufacturer
- Bryant Ranch Prepack
- Strength
- .1 mg/1
- Dosage Form
- TABLET
- Route
- ORAL
- Marketing Status
- Application #
- ANDA070886
- Marketing Start
- 06/02/2021
Recall History
Boehringer Ingelheim Pharmaceuticals, Inc.
An extraneous peak was observed for dissolution testing.
Mutual Pharmaceutical Company, Inc.
cGMP Deviations; Clonidine hydrochloride drug substance used in the manufacturing of this product, was dispensed in unauthorized rooms by the drug substance manufacturer
UNICHEM PHARMACEUTICALS USA INC
Failed Impurities/Degradation Specifications: potential migration of benzophenone at very low level into the product from container.
UNICHEM PHARMACEUTICALS USA INC
Failed Impurities/Degredation Specifications: This recall is initiated as a precautionary measure due to potential migration of Benzophenone at very low level into product from container label.
Boehringer Ingelheim Pharmaceuticals, Inc.
An extraneous peak was observed for dissolution testing.
Mutual Pharmaceutical Company, Inc.
cGMP Deviations; Clonidine hydrochloride drug substance used in the manufacturing of this product, was dispensed in unauthorized rooms by the drug substance manufacturer
Boehringer Ingelheim Pharmaceuticals, Inc.
Failed Dissolution Specifications: OOS resultsduring routine stability testing
PD-Rx Pharmaceuticals, Inc.
cGMP Deviations
Mutual Pharmaceutical Company, Inc.
cGMP Deviations; Clonidine hydrochloride drug substance used in the manufacturing of this product, was dispensed in unauthorized rooms by the drug substance manufacturer
Boehringer Ingelheim Pharmaceuticals, Inc.
An extraneous peak was observed for dissolution testing.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
INDICATIONS AND USAGE Clonidine hydrochloride tablets are indicated in the treatment of hypertension. Clonidine hydrochloride tablets may be employed alone or concomitantly with other antihypertensive agents.
Dosage & Administration
DOSAGE AND ADMINISTRATION Adults: The dose of clonidine hydrochloride tablets 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. For questions regarding this product, call Teva at 1-888-838-2872.
Warnings
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. The likelihood of such reactions to discontinuation of clonidine therapy appears to be greater after administration of higher doses or continuation of concomitant beta-blocker treatment and special caution is therefore advised in these situations. Rare instances of hypertensive encephalopathy, cerebrovascular accidents and death have been reported after clonidine withdrawal. When discontinuing therapy with clonidine hydrochloride tablets, the physician should reduce the dose gradually over 2 to 4 days to avoid withdrawal symptomatology. An excessive rise in blood pressure following discontinuation of clonidine hydrochloride tablets therapy can be reversed by administration of oral clonidine hydrochloride or by intravenous phentolamine. If therapy is to be discontinued in patients receiving a beta-blocker and clonidine concurre…
Contraindications
CONTRAINDICATIONS Clonidine hydrochloride tablets should not be used in patients with known hypersensitivity to clonidine (see PRECAUTIONS ).
Drug Interactions
Drug Interactions Clonidine may potentiate the CNS-depressive effects of alcohol, barbiturates or other sedating drugs. If a patient receiving clonidine hydrochloride is also taking tricyclic antidepressants, the hypotensive effect of clonidine may be reduced, necessitating an increase in the clonidine dose. If a patient receiving clonidine is also taking neuroleptics, orthostatic regulation disturbances (e.g., orthostatic hypotension, dizziness, fatigue) may be induced or exacerbated. Monitor heart rate in patients receiving clonidine concomitantly with agents known to affect sinus node function or AV nodal conduction, e.g., digitalis, calcium channel blockers, and beta-blockers. Sinus bradycardia resulting in hospitalization and pacemaker insertion has been reported in association with the use of clonidine concomitantly with diltiazem or verapamil. Amitriptyline in combination with clonidine enhances the manifestation of corneal lesions in rats (see Toxicology ). Based on observations in patients in a state of alcoholic delirium it has been suggested that high intravenous doses of clonidine may increase the arrhythmogenic potential (QT-prolongation, ventricular fibrillation) of h…
Adverse Reactions
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 tablets, 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, halluci…
Frequently Asked Questions
What is Clonidine Hydrochloride used for?
Clonidine Hydrochloride contains Clonidine Hydrochloride. It is a tablet taken oral. Consult your doctor for specific uses.
Is Clonidine Hydrochloride a controlled substance?
Clonidine Hydrochloride is not classified as a controlled substance by the DEA.
What is the generic name for Clonidine Hydrochloride?
The generic name for Clonidine Hydrochloride is Clonidine Hydrochloride. There are 6 other brand versions of Clonidine Hydrochloride.
What is the NDC code for Clonidine Hydrochloride .1 mg/1?
The NDC (National Drug Code) for Clonidine Hydrochloride .1 mg/1 is 72162-2609, listed by Bryant Ranch Prepack.