Clonipres ER Tablet (Extended Release)

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

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.

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 weeks

Menopausal flushing: 0.1 mg to 0.4 mg daily

Alcohol 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.

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

Clonidine is contraindicated to patients with known history of hypersensitivity to Clonidine.

Most side effects of Clonipres ER 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 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.

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 Clonipres ER 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 Clonipres ER ER Tablet.

Overdose may causes Hypotension, Bradicardia, Respiratory Depression, Hypothermia, Sedation, Abnormal Reflexes, Weakness & Miosis.

Centrally acting antihypertensive drugs (central sympatholytic)

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