Clonipres 0.1 mg

INDICATIONS

Clonidine Hydrochloride is indicated in the treatment of hypertension. It may be employed alone or concomitantly with other anti-hypertensive agent. Clonidine hydrochloride is also indicated for the treatment of menopausal flushing, opioid withdrawal & alcohol withdrawal syndrome. Clonidine hydrochloride extended release tablet is indicated for the treatment of attention deficit hyperactivity disorder (ADHD) as monotherapy.

PHARMACOLOGY

Clonidine Hydrochloride stimulates alpha adrenoceptors in the brain stem. With immediate-release clonidine, blood pressure declines within 30 to 60 minutes after an oral dose, the maximum decrease occurring within 2 to 4 hours. Renal blood flow and glomerular filtration rate remain essentially unchanged. Normal postural reflexes are intact; therefore, orthostatic symptoms are mild and infrequent.

DOSAGE & ADMINISTRATION

Adult: The dose of Clonidine must be adjusted according to the patient's individual blood pressure response.Initial dose: 0.1 mg twice a day (morning & bed time). Elderly patients may be benefited 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 result is achieved. The therapeutic dose most commonly employed have ranged from 0.2 mg to 0.6 mg per day given in divided doses. In renal impairment, dose of Clonidine Hydrochloride must be adjusted according to the degree of impairment & patient should be monitored carefully.Attention deficit hyperactivity disorder: Clonidine IR 5 mcg/kg/day or Clonidine ER 0.1 mg/day for 8 weeksMenopausal flushing: 0.1 mg to 0.4 mg dailyAlcohol withdrawal: 0.3 to 0.6 mg every 6 hourly or as directed by the physician.Use in Children & Adolescents: Safety and effectiveness in pediatric patients have not been established in adequate and well-controlled trials.

INTERACTION

Clonidine may potentiate CNS depressive effect of alcohol, barbiturates or other sedative drugs. Hypotensive effect may be reduced if a patient receives Clonidine and tricyclic anti-depressant; where increased dose of Clonidine is required. Due to a potential for additive effects (such as bradycardia & A.V. block) caution is warranted in patients receiving Clonidine concomitantly with agents (e.g. digitalis, calcium channel blockers & β-blockers) known to affect sinus node function or A.V. nodal conduction.

SIDE EFFECTS

Most side effects of Clonidine are mild and tend to diminish with continued therapy. The most frequent side effects (which appears to be dose related) are dry mouth, drowsiness, dizziness, constipation and sedation, ear pain, irritability, constipation, diarrhea, abdominal pain & nausea.

PREGNANCY & LACTATION

Pregnancy Category C. So, Clonidine should be avoided during pregnency. As Clonidine is excreted in human milk, caution should be exercised when Clonidine is administered to nursing mother.

PRECAUTIONS & WARNINGS

Instruct patients not to discontinue therapy without consulting their physician. Sudden cessation of clonidine treatment has 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. When discontinuing therapy with Clonidine ER Tablet, reduce the dose gradually over 2 to 4 days to avoid withdrawal symptoms. If therapy is to be discontinued in patients receiving a beta-blocker and clonidine concurrently, the beta-blocker should be withdrawn several days before the gradual discontinuation of Clonidine ER Tablet.

THERAPEUTIC CLASS

Centrally acting antihypertensive drugs (central sympatholytic)

STORAGE CONDITIONS

Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.