Noflash Tablet
Clonidine Hydrochloride
0.1 mg
Veritas Pharmaceuticals Ltd.
| Pack size | 60's pack |
|---|---|
| Dispensing mode | |
| Source | |
| Agent | |
| Retail Price | 8.00 AED |
Indications
Noflash Tablet is used for:
Hypertension, Menopausal flushing, Hypertensive crisis, Recurrent migraine, Vascular headache
Adult Dose
Oral
Hypertension
Adult:
Immediate-release tablets
0.1 mg 12 hourly
Range: 0.1-0.2 mg/day 12 hourly; increased every 2nd or 3rd day according to response.
Max: 2.4 mg daily.
Extended-release tablets
Starting dosage is 0.1 mg once daily at bedtime.
Dosage may be increased in increments of 0.1 mg per day at weekly intervals.
The maximum recommended dosage is 0.4 mg once daily at bedtime.
Prevention of recurrent migraine, Prevention of vascular headache, Menopausal symptoms, particularly flushing and vasomotor conditions
Adult: 50 mcg bid, increased to 75 mcg bid if no remission after 2 wk.
Child Dose
<12 years old: Safety and efficacy not established
Hypertension
>12 years old
Immediate-release tablets: 0.2 mg/day PO divided 12 hourly; increase once weekly;
Maintenance dose range, 0.2-0.6 mg/day 12 hourly; not to exceed 2.4 mg/day
Attention Deficit Hyperactivity Disorder (ADHD)
Indicated for ADHD as monotherapy and as adjunctive therapy to CNS stimulant medications in pediatric patients aged >6 years
<6 years: Safety and efficacy not established
>6 years
Extended-release tablets
0.1 mg every night at bedtime initially; individualize dose by increments of 0.1 mg/day at weekly intervals until desired response;
Not to exceed 0.4 mg/day divided BID
Renal Dose
Renal Impairment
Impact of renal impairment not assessed
Initial dose adjustment should be based on amount of renal impairment
Monitor carefully for hypotension and bradycardia
Removed minimally during hemodialysis; no need to redose following dialysis
Administration
Oral Administratioin
May be taken with or without food.
Immediate-release tablets
May administer with or without food
The dose must be adjusted according to the patient’s individual blood pressure response
Increments of 0.1 mg per day may be made at weekly intervals if necessary until desired response achieved; taking the larger portion of the oral daily dose at bedtime may minimize transient adjustment effects of dry mouth and drowsiness; therapeutic doses most commonly used have ranged from 0.2 mg to 0.6 mg per day given in divided doses; studies have indicated that 2.4 mg is maximum effective daily dose, but rarely used
Extended-release tablets
Substitution of extended-release for other clonidine products on an mg-per-mg basis not recommended
Doses 0.2 mg/day or greater should be divided BID, with either an equal or higher split dosage being given at bedtime
Tablet must be swallowed whole, never crushed, cut, or chewed, and may be taken with or without food; when initiating treatment, provide dosage escalation instructions
Missed dose: Skip missed dose and take next dose as scheduled; do not take more than prescribed total daily amount in any 24-hr period
Contra Indications
History of a hypersensitivity reaction to clonidine.
Disorders of cardiac pacemaker activity and conduction.
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.
Avoid concomitant use of drugs with additive effects unless clinically indicated. Advise patients to avoid becoming dehydrated or overheated.
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 Clonidine.
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.
Monitoring Parameters
Measure heart rate and blood pressure prior to initiation of therapy, following dose increases, and periodically while on therapy.
Pregnancy-Lactation
Pregnancy
Prolonged experience with clonidine in pregnant women over several decades, based on published literature, including controlled trials, a retrospective cohort study and case reports, have not identified a drug associated risk of major birth defects, miscarriage, and adverse maternal or fetal outcomes
Based on findings in animal studies revealed that drug may impair fertility in females and males of reproductive potential
Animal data
In animal embryofetal studies, increased resorptions were seen in rats and mice administered oral clonidine hydrochloride from implantation through organogenesis at 10 and 5 times, respectively, the maximum recommended human dose (MRHD) given to adolescents on a mg/m2 basis; no developmental effects were seen in rabbits administered drug during organogenesis at doses up to 3 times the MRHD
Lactation
Based on published lactation studies, clonidine hydrochloride is present in human milk at relative infant doses ranging from 4.1 to 8.4% of maternal weight-adjusted dosage; although in most cases, there were no reported adverse effects in breastfed infants exposed to clonidine, there is one case report of sedation, hypotonia, and apnea in an infant exposed to clonidine through breast milk; if an infant is exposed to clonidine hydrochloride through breastmilk, monitor for symptoms of hypotension and bradycardia, such as sedation, lethargy, tachypnea and poor feeding
Consider developmental and health benefits of breastfeeding along with mother’s clinical need for therapy and any potential adverse effects on breastfed child from drug or from underlying maternal condition; exercise caution when drug is administered to a nursing woman
Monitor breastfeeding infants exposed to drug through breast milk for symptoms of hypotension and/or bradycardia such as sedation, lethargy, tachypnea, and poor feeding
Interactions
CNS Depressants: Clonidine may potentiate the CNS-depressive effects of alcohol, barbiturates or other sedating drugs.
Tricyclic Antidepressants: May reduce the hypotensive effect of clonidine.
Drugs Known to Affect Sinus Node Function or AV Nodal Conduction:
Avoid use of Clonidine XR with agents known to affect sinus node function or AV nodal conduction (e.g., digitalis, calcium channel blockers and betablockers) due to a potential for additive effects such as bradycardia and AV block.
Antihypertensive drugs: Use caution when coadministered with Clonidine XR.
Hypotensive action may be potentiated by diuretics and vasodilators.
Effects of clonidine antagonised by TCAs and centrally-acting alpha-blockers.
May enhance toxicity due to digitalis, lithium.
May antagonise oral hypoglycemic.
Contraindicated (1)
thalidomide
Potentially Fatal: Hypnosedatives, antihistamines and alcohol may cause excessive drowsiness in patients on clonidine. Withdrawal of clonidine in patients receiving noncardioselective beta-blockers may result in rebound BP. Acute severe hypotension following concomitant administration of clonidine and chlorpromazine or haloperidol.
Adverse Effects
Side effects of Clonidine Hydrochloride :
>10%
Skin reactions; patch (15-50%),Dry mouth (40%),Somnolence (19-38%),Headache (19-29%),Fatigue (13-24%),Drowsiness (33%),Dizziness (13-16%),Hypotension, epidural (45%),Postural hypotension, epidural (32%),Anxiety (11%)
1-10%
Constipation (10%),Sedation (10%),Nausea/vomiting, PO (5%),Malaise (3%),Orthostatic hypotension (3%),Anorexia, PO (1%),Abnormal LFTs (1%),Rash (1%),Weight gain, PO (1%)
Frequency Not Defined
Children with ADHD
Upper respiratory tract infection,Irritability,Throat pain,Nightmares,Insomnia,Emotional disorder,Constipation,Nasal congestion
Potentially Fatal: Transient hypertension or profound hypotension, respiratory depression, convulsion. Clonidine withdrawal syndrome could be life threatening. Bradycardia, coma and disturbances in conduction (in individuals with preexisting diseases of SA/AV nodes, overdose or on digitalis).
Mechanism of Action
Clonidine stimulates alpha-2 receptors in brain stem which results in reduced sympathetic outflow from the CNS and a decrease in peripheral resistance leading to reduced BP and pulse rate. It does not alter normal haemodynamic response to exercise at recommended dosages.
Note
Noflash 0.1 mg Tablet manufactured by Veritas Pharmaceuticals Ltd.. Its generic name is Clonidine Hydrochloride. Noflash is availble in Bangladesh.
Farmaco BD drug index information on Noflash Tablet is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.