Tenoren PLUS Tablet

Hypertension

Adult: Oral Per tab contains Atenolol (mg)/Chlorthalidone (mg): 50/25 or 100/25. Hypertension Not indicated for initial therapy If the fixed dose combination represents the dose appropriate to the individual patient's needs, it may be more convenient than the separate components Initial dose: 50 mg atenolol/25 mg chlorthalidone once daily May increase to 100 mg atenolol/25 mg chlorthalidone once daily if needed When necessary, another antihypertensive agent may be added gradually beginning with 50 percent of the usual recommended starting dose to avoid an excessive fall in blood pressure

Renal Impairment Use caution in dosing/titrating patients with renal dysfunction Cumulative effects of thiazides may develop with impaired renal function CrCl > 35 mL/min/1.73 m²: Dose adjustment not necessary CrCl 15-35 mL/min/1.73 m²: Maximum 50 mg PO qDay CrCl <15 mL/min/1.73 m²: Maximum 25 mg PO qDay or 50 mg PO every other day Anuria: Contraindicated

Reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and concomitant disease or other drug therapy.

Hepatic Impairment Not studied; use caution

Sinus bradycardia, 2nd or 3rd degree heart block, cardiogenic shock, anuria, hypersentivity to either product or sulphonamide derivatives.

Chronically administered beta-blocking therapy should not be routinely withdrawn prior to major surgery, however, the impaired ability of the heart to respond to reflex adrenergic stimuli may augment the risks of general anesthesia and surgical procedures. Atenolol and chlorthalidone tablets should not be given to patients with untreated pheochromocytoma. Atenolol and chlorthalidone tablets may aggravate peripheral arterial circulatory disorders. In patients receiving thiazides, sensitivity reactions may occur with or without a history of allergy or bronchial asthma; possible exacerbation or activation of systemic lupus erythematosus reported; antihypertensive effects of thiazides may be enhanced in post sympathectomy patients. Cardiac failure Sympathetic stimulation is necessary in supporting circulatory function in congestive heart failure, and beta-blockade carries the potential hazard of further depressing myocardial contrac­tility and precipitating more severe failure In patients without history of cardiac failure, continued depression of myocardium with beta-blocking agents over a period of time can, in some cases, lead to cardiac failure; at first sign or symptom of impending cardiac failure, patients should be treated appropriately according to currently recommended guidelines, and response observed closely; if cardiac failure continues despite adequate treatment, atenolol and chlorthalidone should be withdrawn. Ischemic heart disease Following abrupt cessation of therapy with certain beta-blocking agents in patients with coronary artery disease, exacerbations of angina pectoris and, in some cases, myocardial infarction have been reported; such patients should be cautioned against interruption of therapy without physician’s advice Even in absence of overt angina pectoris, when discontin­uation of atenolol and chlorthalidone is planned, the patient should be carefully observed and should be advised to limit physical activity to a minimum. Bronchospastic di

Not Classi Pregnancy Atenolol can cause fetal harm when administered to a pregnant woman; atenolol crosses placental barrier and appears in cord blood; administration of atenolol, starting in second trimester of pregnancy, has been associated with birth of infants that are small for gestational age; no studies have been performed on the use of atenolol in first trimester and possibility of fetal injury cannot be excluded If this drug is used during pregnancy, or if patient becomes pregnant while taking this drug, the patient should be apprised of potential hazard to fetus Neonates born to mothers who are receiving atenolol at parturition may be at risk for hypoglycemia and bradycardia; exercise caution when atenolol and chlorthalidone is administered during pregnancy or to a woman who is breastfeeding No teratogenic or embryotoxic effects demonstrated in rat and rabbit Atenolol Atenolol has been shown to produce a dose-related increase in embryo/fetal resorptions in rats at doses 25 or more times maximum recommended human antihypertensive dose; although similar effects were not seen in rabbits, the compound was not evaluated in rabbits at doses above 25 mg/kg/day or 12.5 times maximum recommended human antihypertensive dose, based on maximum dose of 100 mg/day in a 50 kg patient Chlorthalidone Thiazides cross placental barrier and appear in cord blood; the use of chlorthalidone and related drugs in pregnant women requires that anticipated benefits of the drug be weighed against possible hazards to the fetus; these hazards include fetal or neonatal jaundice, thrombocytopenia and possibly other adverse reactions which have occurred in the adult Lactation Atenolol is excreted in human breast milk at ratio of 1.5 to 6.8 when compared to concentration in plasma; caution should be exercised when atenolol is administered to a nursing woman; clinically significant bradycardia has been reported in breastfed infants; premature infants, or infants with impaired renal function, may be more likely to develop adverse effects Neonates born to mothers who are receiving atenolol at parturition or breastfeeding may be at risk for hypoglycemia and bradycardia; caution should be exercised when atenolol and chlorthalidone is administered during pregnancy or to a woman who is breastfeeding

Bradycardia and heart block can occur and the left ventricular end-diastolic pressure can rise when beta-blockers are administered with verapamil or diltiazem; patients with pre-existing conduction abnormalities or left ventricular dysfunction are particularly susceptible; calcium channel blockers may have additive effect when given with atenolol and chlorthalidone Atenolol and chlorthalidone may potentiate action of other antihypertensive agents used concomitantly; patients treated with atenolol and chlorthalidone plus a catecholamine depletor (eg, reserpine) should be closely observed for evidence of hypotension and/or marked bradycardia which may produce vertigo, syncope, or postural hypotension Disopyramide is a Type I antiarrhythmic drug with potent negative inotropic and chronotropic effects. Disopyramide has been associated with severe bradycardia, asystole and heart failure when administered with beta-blockers. Amiodarone is an antiarrhythmic agent with negative chronotropic properties that may be additive to those seen with beta-blockers. Thiazides may decrease arterial responsiveness to norepinephrine. This diminution is not sufficient to preclude the therapeutic effectiveness of norepinephrine. Thiazides may increase the responsiveness to tubocurarine. Concomitant use of prostaglandin synthase inhibiting drugs, eg, indomethacin, may decrease hypotensive effects of beta blockers Lithium generally should not be given with diuretics because they reduce renal clearance and add a high risk of lithium toxicity Beta-blockers may exacerbate the rebound hypertension which can follow withdrawal of clonidine; if the two drugs are coadministered, the beta blocker should be withdrawn several days before the gradual withdrawal of clonidine; if replacing clonidine by beta-blocker therapy, the introduction of beta-blockers should be delayed for several days after clonidine administration has stopped While taking beta-blockers, patients with a history of anaphylactic reaction to a variety of allergens may have a more severe reaction on repeated challenge, either accidental, diagnostic, or therapeutic; such patients may be unresponsive to usual doses of epinephrine used to treat allergic reaction Both digitalis glycosides and beta-blockers slow atrioventricular conduction and decrease heart rate; concomitant use can increase risk of bradycardia Contraindicated (0) Serious - Use Alternative (31) acebutolol aminolevulinic acid oral aminolevulinic acid topical betaxolol bisoprolol carvedilol celiprolol clonidine digoxin diltiazem esmolol fexinidazole isocarboxazid labetalol lofexidine mavacamten methyl aminolevulinate metoprolol nadolol nebivolol penbutolol pindolol propranolol rivastigmine saquinavir sotalol squill timolol tretinoin tretinoin topical verapamil

No adverse effects specific to the combination have been observed; adverse effects limited to those previously reported with atenolol and chlorthalidone Atenolol: Dyspnoea, wheeziness, bradycardia, hypotension, cold extremities, fatigue, dizziness, insomnia, lethargy, confusion, headache, depression, nightmares, nausea, diarrhoea, constipation, impotence, paraesthesia, rash, Raynaud's phenomenon. Chlorthalidone: Orthostatic hypotension, GI disturbances, jaundice, pancreatitis, vertigo, lethargy, paraesthesia, photosensitivity, rash, muscle cramps, hypokalaemia, hyponatraemia, hyperglycaemia, hyperuricaemia or gout, leucopenia, agranulocytosis, aplastic anaemia, thrombocytopenia. Potentially Fatal: Atenolol: Heart failure, 2nd or 3rd degree AV block. Chlorthalidone: Hypersensitivity reaction including toxic epidermal necrolysis.

Atenolol is a beta-blocker that acts preferentially on the ?1 adrenergic receptors in the heart. Chlorthalidone is a thiazide-like diuretic that reduces BP possibly by inhibiting sodium reabsorption at the beginning of the distal convulated tubule. Combination of the two drugs results in additive antihypertensive action.

Tenoren PLUS 50mg + 25mg Tablet manufactured by ACI Limited. Its generic name is Atenolol + Chlorthalidone.