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Co-Diovan

Angiotensin II antagonists combination (valsartan) with diuretic (hydrochlorothiazide)

 

COMPOSITION AND

PHARMACEUTICAL FORM

Active substances: (S)-N-valeryl-N-{[2'-(1H-tetrazol-5-yl)biphenyl-4-yl]methyl}-valine (INN = valsartan) and 6-chloro-3,4-dihydro-2H-1, 2, 4-benzothiadiazine 7-sulfonamide 1,1-dioxide (= hydrochlorothiazide). One tablet contains 80 mg valsartan and 12.5 mg hydrochlorothiazide, or 160 mg valsartan and 12.5 mg hydrochlorothiazide, or 160 mg valsartan and 25 mg hydrochlorothiazide, or 320 mg valsartan and 12.5 mg hydrochlorothiazide, or 320 mg valsartan and 25 mg hydrochlorothiazide. For excipients, see section EXCIPIENTS.

 

Co-Diovan 80/12.5 mg: Ovaloid, non-divisible, film-coated tablets measuring approximately 10.2 mm by 5.4 mm and 3.7 mm in thickness, and weighing approximately 156 mg. The tablets are coloured light orange and imprinted with HGH on one side and CG on the other side.

 

Co-Diovan 160/12.5 mg: Ovaloid, non-divisible, film-coated tablets measuring approximately 15.2 mm by 6.2 mm and 4.4 mm in thickness, and weighing approximately 312 mg. The tablets are coloured dark red and imprinted with HHH on one side and CG on the other side.

 

Co-Diovan 160/25 mg: Ovaloid, non-divisible, film-coated tablets measuring approximately 14.2 mm by 5.7 mm and 4.5 mm in thickness, and weighing approximately 310 mg. The tablets are coloured brown-orange and imprinted with HXH on one side and NVR on the other side.

 

Co-Diovan 320/12.5 mg: Ovaloid, non-divisible, film-coated tablets measuring approximately 17.7 mm by 8.2 mm and 5.6mm in thickness, and weighing approximately 608 mg. The tablets are coloured pink and imprinted with HIL on one side and NVR on the other side.

 

Co-Diovan 320/25 mg: Ovaloid, non-divisible, film-coated tablets measuring approximately 17.7 mm by 8.2 mm and 5.6mm in thickness, and weighing approximately 620 mg. The tablets are coloured yellow and imprinted with CTI on one side and NVR on the other side.

 

Appearance of tablets may vary between countries. Certain dosage strengths may not be available in all countries.

 

INDICATIONS

Treatment of hypertension. Co-Diovan is indicated for the treatment of hypertension in patients whose blood pressure is not adequately controlled by monotherapy. These fixed dose combinations should be used as second-line therapy.

 

DOSAGE AND ADMINISTRATION

The recommended dose of Co-Diovan is 1 coated tablet per day. When clinically appropriate either 80 mg valsartan and 12.5 mg hydrochlorothiazide or 160 mg valsartan and 12.5 mg hydrochlorothiazide or 320 mg valsartan and 12.5 mg hydrochlorothiazide may be used. When necessary 160 mg valsartan and 25 mg hydrochlorothiazide or 320 mg valsartan and 25 mg hydrochlorothiazide may be used. The maximum antihypertensive effect is seen within 2 to 4 weeks. No dosage adjustment is required for patients with mild to moderate renal impairment (creatinine clearance > 30 mL/min). No dosage adjustment is required in patients with mild to moderate hepatic insufficiency of non-biliary origin and without cholestasis (see section SPECIAL WARNINGS AND PRECAUTIONS FOR USE). The safety and efficacy of Co-Diovan have not been established in children.

 

CONTRAINDICATIONS

Hypersensitivity to valsartan, hydrochlorothiazide, other sulfonamides or to any of the excipients of Co-Diovan. Pregnancy (see section PREGNANCY AND LACTATION). Severe hepatic impairment, biliary cirrhosis and cholestasis. Anuria, severe renal impairment (creatinine clearance < 30 mL/min). Refractory hypokalemia, hyponatremia, hypercalcemia, and symptomatic hyperuricemia.

 

SPECIAL WARNINGS AND PRECAUTIONS FOR USE

Serum electrolyte changes

Concomitant use with potassium supplements, potassium- sparing diuretics, salt substitutes containing potassium, or other drugs that may increase potassium levels (heparin, etc.) should be used with caution. Hypokalemia has been reported under treatment with thiazide diuretics. Frequent monitoring of serum potassium is recommended. Treatment with thiazide diuretics, including hydrochlorothiazide, has been associated with hyponatremia and hypochloremic alkalosis. Thiazides, including hydrochlorothiazide, increase the urinary excretion of magnesium, which may result in hypomagnesemia.

 

Sodium- and/or volume-depleted patients

In severely sodium-depleted and/or volume-depleted patients, such as those receiving high doses of diuretics, symptomatic hypotension may occur in rare cases after initiation of therapy with Co-Diovan. Sodium and/or volume depletion should be corrected before starting treatment with Co-Diovan. If hypotension occurs, the patient should be placed in the supine position and, if necessary, given an i.v. infusion of normal saline. Treatment can be continued once the blood pressure has stabilized.

 

Renal artery stenosis

In patients with unilateral or bilateral renal artery stenosis or stenosis to a solitary kidney, the safe use of Co-Diovan has not been established.

 

Renal impairment

No dosage adjustment is required for patients with renal impairment (creatinine clearance > 30 mL/min).

 

Hepatic impairment

In patients with mild to moderate hepatic impairment without cholestasis, no dosage adjustment is required. However, Co-Diovan should be used with caution. Liver disease does not significantly alter the pharmacokinetics of hydrochlorothiazide.

 

Systemic lupus erythematosus

Thiazide diuretics, including hydrochlorothiazide, have been reported to exacerbate or activate systemic lupus erythematosuss.

 

Other metabolic disturbances

Thiazide diuretics, including hydrochlorothiazide, may alter glucose tolerance and raise serum levels of cholesterol, triglycerides, and uric acid.

 

INTERACTIONS

The antihypertensive effect may be increased with concomitant use of other antihypertensive drugs. Concomitant use with potassium supplements, potassium-sparing diuretics, salt substitutes containing potassium, or other drugs that may alter potassium levels (heparin, etc.) should be used with caution and with frequent monitoring of potassium. Reversible increases in serum lithium concentrations and toxicity have been reported during concurrent use of ACE inhibitors and thiazides. There is no experience with concomitant use of valsartan and lithium. Therefore, monitoring of serum lithium concentrations is recommended during concurrent use. In monotherapy with valsartan, no drug interactions of clinical significance have been found with the following drugs: cimetidine, warfarin, furosemide, digoxin, atenolol, indomethacin, hydrochlorothiazide amlodipine, glibenclamide. The following potential drug interactions may occur due to the thiazide component of Co-Diovan: Thiazides, including hydrochlorothiazide, potentiate the action of curare derivatives.

Concomitant administration of NSAIDs (e.g. salicylic acid derivative, indomethacin) may weaken the diuretic and antihypertensive activity of the thiazide component of Co-Diovan. Concurrent hypovolemia may induce acute renal failure.

The hypokalemic effect of diuretics may be increased by kaliuretic diuretics, corticosteroids, ACTH, amphotericin, carbenoxolone, penicillin G, salicylic acid derivatives.

Thiazide-induced hypokalemia or hypomagnesemia may occur as unwanted effects, favouring the onset of digitalis-induced cardiac arrhythmias. It may prove necessary to readjust the dosage of insulin and of oral antidiabetic agents. Co-administration of thiazide diuretics, including hydrochlorothiazide, may increase the incidence of hypersensitivity reactions to allopurinol, may increase the risk of adverse effects caused by amantadine, may enhance the hyperglycemic effect of diazoxide, and may reduce the renal excretion of cytotoxic drugs (e.g. cyclophosphamide, methotrexate) and potentiate their myelosuppressive effects.

The bioavailability of thiazide-type diuretics may be increased by anticholinergic agents (e.g. atropine, biperiden apparently due to a decrease in gastrointestinal motility and the stomach emptying rate.

There have been reports in the literature of haemolytic anaemia occurring with concomitant use of hydrochlorothiazide and methyldopa.

Absorption of thiazide diuretics, including hydrochlorothiazide, is decreased by cholestyramine. Administration of thiazide diuretics, including hydrochlorothiazide, with vitamin D or with calcium salts may potentiate the rise in serum calcium.

Concomitant treatment with cyclosporine may increase the risk of hyperuricemia and gout-type complications.

 

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