Drug Facts
Composition & Profile
Identifiers & Packaging
16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied ONYDA XR (clonidine hydrochloride) extended-release oral suspension 0.1 mg/mL is a light beige to tan viscous suspension. ONYDA XR is supplied in a carton. Each carton contains one bottle with a child resistant closure, an oral dosing dispenser(s), and a press in bottle adapter(s). Bottle of 30 mL NDC 24478-148-03 One (1) oral dosing dispenser and one (1) press in bottle adapter Bottle of 60 mL NDC 24478-148-04 One (1) oral dosing dispenser and one (1) press in bottle adapter Bottle of 120 mL NDC 24478-148-02 Two (2) oral dosing dispensers and two (2) press in bottle adapters Storage and Handling Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Protect from light. Store and dispense ONYDA XR in the original bottle. Dispense with bottle adapter and oral dosing dispenser supplied in the carton. For the bottles of 30 mL and 60 mL, discard any unused ONYDA XR 30 days after first opening the bottle. For the 120 mL bottle, discard any unused ONYDA XR 60 days after first opening the bottle.; PRINCIPAL DISPLAY PANEL NDC 24478-148-01 ONYDA TM XR (clonidine hydrochloride) extended-release oral suspension 0.1 mg Shake Gently Before Use 7 mL Rx only 7mLlabel; PRINCIPAL DISPLAY PANEL NDC 24478-148-01 ONYDA TM XR (clonidine hydrochloride) extended-release oral suspension 0.1 mg Shake Gently Before Use 7 mL Rx only 7mLcarton; PRINCIPAL DISPLAY PANEL NDC 24478-148-03 ONYDA TM XR (clonidine hydrochloride) extended-release oral suspension 0.1 mg Shake Gently Before Use 30 mL Rx only 30mLlabel; PRINCIPAL DISPLAY PANEL NDC 24478-148-03 ONYDA TM XR (clonidine hydrochloride) extended-release oral suspension 0.1 mg Shake Gently Before Use 30 mL Rx only 30mLcarton
- 16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied ONYDA XR (clonidine hydrochloride) extended-release oral suspension 0.1 mg/mL is a light beige to tan viscous suspension. ONYDA XR is supplied in a carton. Each carton contains one bottle with a child resistant closure, an oral dosing dispenser(s), and a press in bottle adapter(s). Bottle of 30 mL NDC 24478-148-03 One (1) oral dosing dispenser and one (1) press in bottle adapter Bottle of 60 mL NDC 24478-148-04 One (1) oral dosing dispenser and one (1) press in bottle adapter Bottle of 120 mL NDC 24478-148-02 Two (2) oral dosing dispensers and two (2) press in bottle adapters Storage and Handling Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Protect from light. Store and dispense ONYDA XR in the original bottle. Dispense with bottle adapter and oral dosing dispenser supplied in the carton. For the bottles of 30 mL and 60 mL, discard any unused ONYDA XR 30 days after first opening the bottle. For the 120 mL bottle, discard any unused ONYDA XR 60 days after first opening the bottle.
- PRINCIPAL DISPLAY PANEL NDC 24478-148-01 ONYDA TM XR (clonidine hydrochloride) extended-release oral suspension 0.1 mg Shake Gently Before Use 7 mL Rx only 7mLlabel
- PRINCIPAL DISPLAY PANEL NDC 24478-148-01 ONYDA TM XR (clonidine hydrochloride) extended-release oral suspension 0.1 mg Shake Gently Before Use 7 mL Rx only 7mLcarton
- PRINCIPAL DISPLAY PANEL NDC 24478-148-03 ONYDA TM XR (clonidine hydrochloride) extended-release oral suspension 0.1 mg Shake Gently Before Use 30 mL Rx only 30mLlabel
- PRINCIPAL DISPLAY PANEL NDC 24478-148-03 ONYDA TM XR (clonidine hydrochloride) extended-release oral suspension 0.1 mg Shake Gently Before Use 30 mL Rx only 30mLcarton
Overview
ONYDA XR contains clonidine hydrochloride, a centrally acting alpha 2 -adrenergic agonist. Clonidine hydrochloride is an imidazoline derivative and exists as a mesomeric compound. The chemical name is 2-[(2,6-dichlorophenyl)imino]imidazolidine hydrochloride. The following is the structural formula: The molecular formula of clonidine hydrochloride is C 9 H 9 C l2 N 3 •HCl and the molecular weight is 266.5. The pKa is 8.05. Clonidine hydrochloride is an odorless, bitter, white to almost white, crystalline powder soluble in water and alcohol. The pH of a 5% solution in water is between 3.5 and 5.5. ONYDA XR is an extended-release suspension for oral administration. Each mL of ONYDA XR contains 0.09 mg clonidine equivalent to 0.1 mg clonidine hydrochloride (0.095 mg clonidine hydrochloride complexed with sodium polystyrene sulfonate and 0.005 mg clonidine hydrochloride). The pH of ONYDA XR is between 2.8 and 4. The inactive ingredients are anhydrous citric acid, edetate disodium, glycerin, modified starch, methylparaben, orange flavor, polyvinyl acetate dispersion 30%, povidone, polysorbate 80, propylparaben, purified water, sucrose, sodium polystyrene sulfonate, triacetin, xanthan gum. Chem Draw Structure
Indications & Usage
ONYDA XR is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) as monotherapy and as adjunctive therapy to central nervous system (CNS) stimulant medications in pediatric patients 6 years of age and older [see Clinical Studies ( 14 )]. ONYDA XR is a centrally acting alpha 2 -adrenergic agonist indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) as monotherapy or as adjunctive therapy to central nervous system (CNS) stimulant medications in pediatric patients 6 years of age and older. ( 1 )
Dosage & Administration
Starting dosage is 0.1 mg of ONYDA XR orally once daily at bedtime with or without food. Dosage may be increased in increments of 0.1 mg per day at weekly intervals. Maximum recommended dosage is 0.4 mg once daily at bedtime. ( 2.1 ) Do not substitute ONYDA XR for other clonidine products on a mg-per-mg basis because of differing pharmacokinetic profiles. ( 2.3 ) When discontinuing, taper the dose in decrements of no more than 0.1 mg every 3 to 7 days to avoid rebound hypertension. ( 2.4 ) 2.1 Recommended Dosage The starting dosage of ONYDA XR is 0.1 mg orally once daily at bedtime with or without food [see Clinical Pharmacology ( 12.3 )] . Titrate the dose of ONYDA XR in increments of 0.1 mg per day at weekly intervals depending on clinical response up to the maximum recommended dosage of 0.4 mg once daily at bedtime. Doses of ONYDA XR higher than 0.4 mg once daily were not evaluated in clinical trials for ADHD and are not recommended. When ONYDA XR is added to a CNS stimulant, adjust the dose of the CNS stimulant depending on the clinical response to ONYDA XR. 2.2 Administration Instructions Instruct patients to read the “Instructions for Use” for complete administration instructions. Use the oral dosing dispenser and bottle adapter provided with ONYDA XR. Ensure that the bottle adapter is firmly inserted into the bottle before first use and keep the adapter in place for the duration of the usage of the bottle. Gently shake ONYDA XR with a smooth up and down motion (to avoid foaming) for at least 10 seconds before each administration. For the bottles of 30 mL and 60 mL, discard any unused ONYDA XR 30 days after first opening the bottle. For the 120 mL bottle, discard any unused ONYDA XR 60 days after first opening the bottle. 2.3 Switching from Other Clonidine Products For patients switching from another clonidine product, discontinue that treatment, and titrate with ONYDA XR using the titration schedule [see Dosage and Administration ( 2.1 )] . Do not substitute for other clonidine products on a milligram-per-milligram basis because of differing pharmacokinetic profiles [see Clinical Pharmacology ( 12.3 )]. 2.4 Discontinuation When discontinuing ONYDA XR, taper the total daily dose in decrements of no more than 0.1 mg every 3 to 7 days to avoid rebound hypertension [see Warnings and Precautions ( 5.3 )]. 2.5 Missed Doses If a dose of ONYDA XR is missed, skip that dose and take the next dose as scheduled. Do not take more than the prescribed total daily amount of ONYDA XR in any 24-hour period.
Warnings & Precautions
Hypotension/bradycardia: Titrate slowly and monitor vital signs frequently in patients at risk for hypotension, heart block, bradycardia, syncope, cardiovascular disease, vascular disease, cerebrovascular disease, or chronic renal failure. Measure heart rate and blood pressure prior to initiation of therapy, following dose increases, and periodically while on therapy. Avoid concomitant use of drugs with additive effects unless clinically indicated. Advise patients to avoid becoming dehydrated or overheated. ( 5.1 ) Somnolence/Sedation: Has been observed with clonidine. Consider the potential for additive sedative effects with CNS depressant drugs. Caution patients against operating heavy equipment or driving until they know how they respond to ONYDA XR ( 5.2 ) Cardiac Conduction Abnormalities: May worsen sinus node dysfunction and atrioventricular (AV) block, especially in patients taking other sympatholytic drugs. Titrate slowly and monitor vital signs frequently. ( 5.5 ) 5.1 Hypotension/Bradycardia Treatment with ONYDA XR can cause dose-related decreases in blood pressure and heart rate [see Adverse Reactions ( 6.1 )]. Measure heart rate and blood pressure prior to initiation of therapy, following dose increases, and periodically while on therapy. Titrate ONYDA XR slowly in patients with a history of hypotension, and those with underlying conditions that may be worsened by hypotension and bradycardia; e.g., heart block, bradycardia, cardiovascular disease, vascular disease, cerebrovascular disease, or chronic renal failure. In patients who have a history of syncope or may have a condition that predisposes them to syncope, such as hypotension, orthostatic hypotension, bradycardia, or dehydration, advise patients to avoid becoming dehydrated or overheated. Monitor blood pressure and heart rate, and adjust dosages accordingly in patients treated concomitantly with antihypertensives or other drugs that can reduce blood pressure or heart rate or increase the risk of syncope [see Drug Interactions ( 7 )] . 5.2 Sedation and Somnolence Somnolence and sedation were commonly reported adverse reactions in clinical studies with clonidine hydrochloride extended-release tablets. In patients that completed 5 weeks of therapy in a controlled, fixed dose pediatric monotherapy study, 31% of patients treated with 0.4 mg/day and 38% treated with 0.2 mg/day versus 4% of placebo treated patients reported somnolence as an adverse reaction. In patients that completed 5 weeks of therapy in a controlled flexible dose pediatric adjunctive to stimulants study, 19% of patients treated with clonidine hydrochloride extended-release tablets plus a stimulant versus 7% treated with placebo plus a stimulant reported somnolence. Before using ONYDA XR with other centrally active depressants (such as phenothiazines, barbiturates, or benzodiazepines), consider the potential for additive sedative effects [see Drug Interactions ( 7 )] . Caution patients against operating heavy equipment or driving until they know how they respond to treatment with ONYDA XR. Advise patients to avoid use with alcohol. 5.3 Rebound Hypertension Abrupt discontinuation of ONYDA XR can cause rebound hypertension. In adults with hypertension, sudden cessation of clonidine extended-release formulation treatment in the 0.2 to 0.6 mg per day range resulted in reports of headache, tachycardia, nausea, flushing, warm feeling, brief lightheadedness, tightness in chest, and anxiety. In adults with hypertension, sudden cessation of treatment with immediate-release clonidine 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. Pediatric patients with gastrointestinal illnesses that lead to vomiting may result in missed doses of ONYDA XR, increasing the risk for rebound hypertension. No studies evaluating abrupt discontinuation of clonidine hydrochloride extended-release tablets in pediatric patients with ADHD have been conducted; however, to minimize the risk of rebound hypertension, gradually reduce the dose of ONYDA XR in decrements of no more than 0.1 mg every 3 to 7 days. Patients should be instructed not to discontinue ONYDA XR therapy without consulting their physician due to the potential risk of withdrawal effects. 5.4 Allergic Reactions In patients who have developed localized contact sensitization to clonidine transdermal system, continuation of clonidine transdermal system or use of oral ONYDA XR therapy may be associated with the development of a generalized skin rash. In patients who develop an allergic reaction from clonidine transdermal system, use of ONYDA XR may also elicit an allergic reaction (including generalized rash, urticaria, or angioedema). 5.5 Cardiac Conduction Abnormalities The sympatholytic action of clonidine may worsen sinus node dysfunction and atrioventricular (AV) block, especially in patients taking other sympatholytic drugs. There have been post-marketing reports of patients with conduction abnormalities and/or taking other sympatholytic drugs who developed severe bradycardia requiring intravenous (IV) atropine, IV isoproterenol, and temporary cardiac pacing while taking clonidine. Titrate ONYDA XR slowly and monitor vital signs frequently in patients with cardiac conduction abnormalities or patients concomitantly treated with other sympatholytic drugs.
Contraindications
ONYDA XR is contraindicated in patients with a history of a hypersensitivity reaction to clonidine. Reactions have included generalized rash, urticaria, and angioedema [see Warnings and Precautions ( 5.4 ) and Adverse Reactions ( 6 )]. History of a hypersensitivity reaction to clonidine. Reactions have included generalized rash, urticaria, angioedema. ( 4 )
Adverse Reactions
The following serious adverse reactions are described in greater detail elsewhere in labeling: Hypotension/bradycardia [see Warnings and Precautions ( 5.1 )] Sedation and somnolence [see Warnings and Precautions ( 5.2 )] Rebound hypertension [see Warnings and Precautions ( 5.3 )] Allergic reactions [see Warnings and Precautions ( 5.4 )] Cardiac Conduction Abnormalities [see Warnings and Precautions ( 5.5 )] Most common adverse reactions (incidence at least 5% and twice the rate of placebo) as monotherapy in ADHD: somnolence, fatigue, irritability, nightmare, insomnia, constipation, dry mouth. ( 6.1 ) Most common adverse reactions (incidence at least 5% and twice the rate of placebo) as adjunct therapy to psychostimulant in ADHD: somnolence, fatigue, decreased appetite, dizziness. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Tris Pharma, Inc. at (732) 940-0358 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trial Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of ONYDA XR for the treatment of ADHD in pediatric patients 6 years and older is based upon adequate and well-controlled studies of clonidine hydrochloride extended-release tablets (referred to as “clonidine hydrochloride extended-release” in this section). The safety results of these adequate and well-controlled studies of clonidine hydrochloride extended-release tablets are presented below. Two clonidine hydrochloride extended-release ADHD clinical studies (Study 1 and Study 2) evaluated 256 patients in two 8-week placebo-controlled studies. A third clonidine hydrochloride extended-release ADHD clinical study (Study 3) evaluated 135 pediatric patients 6 to 17 years of age in a 40-week placebo-controlled randomized‑withdrawal study. Study 1: Fixed-dose clonidine hydrochloride extended-release Monotherapy Study 1 was a short-term, multi-center, randomized, double-blind, placebo-controlled study of two fixed doses (0.2 mg/day or 0.4 mg/day) of clonidine hydrochloride extended-release in pediatric patients 6 to 17 years of age who met DSM-IV criteria for ADHD hyperactive or combined inattentive/hyperactive subtypes. Most Common Adverse Reactions (incidence of ≥ 5% and at least twice the rate of placebo): somnolence, fatigue, irritability, insomnia, nightmare, constipation, dry mouth. Adverse Reactions Leading to Discontinuation of clonidine hydrochloride extended-release: Five patients (7%) in the low dose group (0.2 mg), 15 patients (20%) in the high dose group (0.4 mg), and 1 patient in the placebo group (1%) reported adverse reactions that led to discontinuation. The most common adverse reactions that led to discontinuation were somnolence and fatigue. Commonly observed adverse reactions (incidence of ≥2% in either active treatment group and greater than the rate on placebo) during the treatment period are listed in Table 1 . Table 1: Common Adverse Reactions Occurring in ≥2%of Patients Treated with Clonidine Hydrochloride Extended-Release Tablets and Greater than the Rate of Placebo in the Fixed-Dose Monotherapy Trial -Treatment Period (Study 1) Preferred Term Clonidine hydrochloride extended-release tablets 0.2 mg/day N=76 (%) Clonidine hydrochloride extended-release tablets 0.4 mg/day N=78 (%) Placebo N=76 (%) PSYCHIATRIC DISORDERS Somnolence * Nightmare Emotional Disorder Aggression Tearfulness Enuresis Sleep Terror Poor Quality Sleep 38 4 4 3 1 0 3 0 31 9 4 1 3 4 0 3 4 0 1 0 0 0 0 1 NERVOUS SYSTEM DISORDERS Headache Insomnia Tremor Abnormal Sleep-Related Event 20 5 1 3 13 6 4 1 16 1 0 0 GASTRO-INTESTINAL DISORDERS Upper Abdominal Pain Nausea Constipation Dry Mouth 15 4 1 0 10 5 6 5 12 3 0 1 GENERAL DISORDERS Fatigue † Irritability 16 9 13 5 1 4 CARDIAC DISORDERS Dizziness Bradycardia 7 0 3 4 5 0 INVESTIGATIONS Increased Heart Rate 0 3 0 METABOLISM AND NUTRITION DISORDERS Decreased Appetite 3 4 4 * Somnolence includes the terms "somnolence" and "sedation". † Fatigue includes the terms "fatigue" and "lethargy". Commonly observed adverse reactions (incidence of ≥2% in either active treatment group and greater than the rate on placebo) during the taper period are listed in Table 2 . Table 2: Common Adverse Reactions Occurring in ≥2% of Patients Treated with Clonidine Hydrochloride Extended-Release Tablets and Greater than the Rate of Placebo in the Fixed-Dose Monotherapy Trial -Taper Period* (Study 1) Preferred Term Clonidine hydrochloride extended-release tablets 0.2 mg/day N=76 (%) Clonidine hydrochloride extended-release tablets 0.4 mg/day N=78 (%) Placebo N=76 (%) Abdominal Pain Upper 0 6 3 Headache 5 2 3 Gastrointestinal Viral 0 5 0 Somnolence 2 3 0 Heart Rate Increased 0 3 0 Otitis Media Acute 3 0 0 * Taper Period: 0.2 mg dose, week 8; 0.4 mg dose, weeks 6-8; Placebo dose, weeks 6-8 Study 2: Flexible-dose clonidine hydrochloride extended-release as Adjunctive Therapy to Psychostimulants Study 2 was a short-term, randomized, double-blind, placebo-controlled study of a flexible dose of clonidine hydrochloride extended-release as adjunctive therapy to a psychostimulant in pediatric patients 6 to 17 years of age who met DSM-IV criteria for ADHD hyperactive or combined inattentive/hyperactive subtypes, during which clonidine hydrochloride extended‑release was initiated at 0.1 mg/day and titrated up to 0.4 mg/day over a 3-week period. Most clonidine hydrochloride extended-release treated patients (75.5%) were escalated to the maximum dose of 0.4 mg/day. Most Common Adverse Reactions (incidence of ≥ 5% and at least twice the rate of placebo): somnolence, fatigue, decreased appetite, dizziness. Adverse Reactions Leading to Discontinuation: There was one patient in the clonidine hydrochloride extended-release + stimulant (group (1%) who discontinued because of an adverse event (severe bradyphrenia, with severe fatigue). Commonly observed adverse reactions (incidence of ≥2% in the treatment group and greater than the rate on placebo) during the treatment period are listed in Table 3 . Table 3: Common Adverse Reactions Occurring in ≥2% of Patients Treated with Clonidine Hydrochloride Extended-Release Tablets and Greater than the Rate of Placebo in the Flexible-Dose Adjunctive to Stimulant Therapy Trial -Treatment Period (Study 2) Preferred Term Clonidine hydrochloride extended-release tablets + Stimulant N=102 (%) PBO+Stimulant N=96 (%) PSYCHIATRIC DISORDERS Somnolence+ Aggression Affect Lability Emotional Disorder 19 2 2 2 7 1 1 0 GENERAL DISORDERS Fatigue† Irritability 14 2 4 7 NERVOUS SYSTEM DISORDERS Headache Insomnia 7 4 12 3 GASTRO-INTESTINAL DISORDERS Upper Abdominal Pain 7 4 RESPIRATORY DISORDERS Nasal Congestion 2 2 METABOLISM AND NUTRITION DISORDERS Decreased Appetite 6 3 CARDIAC DISORDERS Dizziness 5 1 + Somnolence includes the terms: "somnolence" and "sedation" † Fatigue includes the terms "fatigue" and "lethargy" Commonly observed adverse reactions (incidence of ≥2% in the treatment group and greater than the rate on placebo) during the taper period are listed in Table 4 . Table 4: Common Adverse Reactions Occurring in ≥2% of Patients Treated with Clonidine Hydrochloride Extended-Release Tablets and Greater than the Rate of Placebo in the Flexible-Dose Adjunctive to Stimulant Therapy Trial -Taper Period + (Study 2) Preferred Term Clonidine hydrochloride extended-release tablets + Stimulant N=102 (%) Placebo+Stimulant N=96 (%) Nasal Congestion 4 2 Headache 3 1 Irritability 3 2 Throat Pain 3 1 Gastroenteritis Viral 2 0 Rash 2 0 + Taper Period: weeks 6-8 Adverse Reactions Leading to Discontinuation Thirteen percent (13%) of patients receiving clonidine hydrochloride extended-release discontinued from the pediatric monotherapy study due to adverse reactions, compared to 1% in the placebo group. The most common adverse reactions leading to discontinuation of clonidine hydrochloride extended-release monotherapy treated patients were somnolence/sedation (5%) and fatigue (4%). Effect on Blood Pressure and Heart Rate In patients that completed 5 weeks of treatment in a controlled, fixed-dose monotherapy study in pediatric patients, during the treatment period the maximum placebo-subtracted mean change in systolic blood pressure was -4.0 mmHg on clonidine hydrochloride extended-release 0.2 mg/day and -8.8 mmHg on clonidine hydrochloride extended-release 0.4 mg/day. The maximum placebo-subtracted mean change in diastolic blood pressure was -4.0 mmHg on clonidine hydrochloride extended-release 0.2 mg/day and -7.3 mmHg on clonidine hydrochloride extended-release 0.4 mg/day. The maximum placebo-subtracted mean change in heart rate was ‑4.0 beats per minute on clonidine hydrochloride extended-release 0.2 mg/day and -7.7 beats per minute on clonidine hydrochloride extended-release 0.4 mg/day. During the taper period of the fixed-dose monotherapy study the maximum placebo-subtracted mean change in systolic blood pressure was +3.4 mmHg on clonidine hydrochloride extended‑release 0.2 mg/day and -5.6 mmHg on clonidine hydrochloride extended-release 0.4 mg/day. The maximum placebo-subtracted mean change in diastolic blood pressure was +3.3 mmHg on clonidine hydrochloride extended-release 0.2 mg/day and -5.4 mmHg on clonidine hydrochloride extended-release 0.4 mg/day. The maximum placebo-subtracted mean change in heart rate was -0.6 beats per minute on clonidine hydrochloride extended-release 0.2 mg/day and -3.0 beats per minute on clonidine hydrochloride extended-release 0.4 mg/day. 6.2 Postmarketing Experience The following adverse reactions have been identified during post-approval use of clonidine hydrochloride extended-release tablets (and excludes those already mentioned in Section 6.1 ). Because these reactions are 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. Psychiatric: hallucinations Cardiovascular: Q-T prolongation
Drug Interactions
The interactions of ONYDA XR with co-administration of other drugs have not been studied. The drug interaction data provided in this section is based on oral immediate-release clonidine formulations. Table 5 displays clinically important drug interactions with ONYDA XR. Table 5: Clinically Important Drug Interactions with ONYDA XR Antihypertensive drugs Clinical Implication Concomitant use of antihypertensive drugs with clonidine potentiates the hypotensive effects of clonidine. Intervention Monitor blood pressure and heart rate, and adjust dosage of ONYDA XR accordingly in patients treated concomitantly with antihypertensives [see Warnings and Precautions ( 5.1 )] . CNS depressants Clinical Implication Concomitant use of CNS depressants with clonidine potentiates the sedating effects [see Warnings and Precautions ( 5.2 )] . Intervention Avoid concomitant use of CNS depressants with ONYDA XR. Drugs that affect sinus node function or AV node conduction (e.g., digitalis, calcium channel blockers, beta blockers) Clinical Implication Concomitant use of drugs that affect sinus node function or AV node conduction with clonidine potentiate bradycardia and risk of AV block [see Warnings and Precautions ( 5.5 )] . Intervention Avoid concomitant use of drugs that affect sinus node function or AV node conduction with ONYDA XR. Tricyclic antidepressants Clinical Implication Concomitant use of tricyclic antidepressants with clonidine can increase blood pressure and may counteract the hypotensive effects of clonidine. Intervention Monitor blood pressure and adjust dosage of ONYDA XR as needed. CNS Depressants: Clonidine may potentiate the CNS-depressive effects of alcohol, barbiturates or other sedating drugs. ( 7 ) Tricyclic Antidepressants: May reduce the hypotensive effect of clonidine. ( 7 ) Drugs Known to Affect Sinus Node Function or AV Nodal Conduction: Avoid use of ONYDA XR with agents known to affect sinus node function or AV nodal conduction (e.g., digitalis, calcium channel blockers and beta-blockers) due to a potential for additive effects such as bradycardia and AV block. ( 7 ) Antihypertensive drugs: Use caution when coadministered with ONYDA XR. ( 7 )
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