Torval H 80/12.5/Torval H 160/12.5

Torval H 80/12.5/Torval H 160/12.5

valsartan + hydrochlorothiazide

Manufacturer:

Torrent

Distributor:

Torrent
Concise Prescribing Info
Contents
Torval H 80/12.5 Valsartan 80 mg, hydrochlorothiazide 12.5 mg. Torval H 160/12.5 Valsartan 160 mg, hydrochlorothiazide 12.5 mg
Dosage/Direction for Use
Patient who is not vol-depleted Monotherapy Valsartan: Initially 80 mg or 160 mg once daily. Patient requiring greater reductions may be started at the higher dose. Valsartan may be used over dose range of 80-320 mg daily, administered once daily. Hydrochlorothiazide: Effective in doses of 12.5-50 mg once daily, & can be given at doses of 12.5-25 mg as valsartan & hydrochlorothiazide. Patient whose BP is not adequately controlled w/ valsartan monotherapy May be switched to 80 mg/12.5 mg or 160 mg/12.5 mg once daily. If BP remains uncontrolled after 3-4 wk of therapy, either valsartan or both components may be increased depending on clinical response. Patient whose BP is inadequately controlled by hydrochlorothiazide 25 mg once daily, or who is controlled but experiences hypokalemia w/ this regimen May be switched to 80 mg/12.5 mg or 160 mg/12.5 mg once daily. If BP remains uncontrolled after 3-4 wk therapy, dose may be titrated up to 160 mg/25 mg.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity. Patients w/ anuria or hypersensitivity to other sulfonamide-derived drugs.
Special Precautions
Not indicated for initial therapy. Perform periodic determinations of serum electrolytes at appropriate intervals. Not recommended in patients w/ severe renal impairment. Discontinue as soon as possible when pregnancy is detected. Valsartan: Correct vol depletion in patients w/ vol depletion (eg, those who have received high-dose diuretic therapy) before starting therapy or use low initial dose. Monitor serum K conc especially in elderly & patients w/ renal impairment. Avoid concomitant use of K-sparing diuretics. Caution in patients w/ hepatic impairment, cirrhosis, or biliary obstruction. Hydrochlorothiazide: Hypersensitivity reactions may occur in patients w/ or w/o history of allergy or bronchial asthma. Reports of exacerbation or activation of SLE. Caution in patients w/ existing fluid & electrolyte disturbances or who are at risk from changes in fluid & electrolyte balance eg, elderly. Hyponatremia may occur in patients w/ severe heart failure who are very edematous particularly w/ large doses & restricted salt intake. Not to be given to patients w/ Addison's disease; pre-existing hypercalcemia. May precipitate attacks of gout in susceptible patients. May cause hyperglycemia & aggravate or unmask DM. Increased risk of non-melanoma skin cancer (basal cell carcinoma & squamous cell carcinoma) w/ increasing cumulative dose of exposure. Regularly check skin for any new lesions & promptly report any suspicious skin lesions. Limit exposure to sunlight & UV rays, & ensure adequate protection in case of exposure in order to minimize risk of skin cancer. Not to be given w/ lithium. Caution in patients w/ hepatic impairment or progressive liver disease; renal impairment. Avoid use in patients w/ severe hepatic impairment. Not to be used in patients w/ anuria.
Adverse Reactions
Headache, dizziness, diarrhea, nausea, constipation, impotence. Valsartan: Vertigo, fatigue, abdominal pain, muscle cramps, dry cough, hypotension, pruritus, rash, dry mouth. Hydrochlorothiazide: Hyperglycemia & glycosuria in diabetic & other susceptible patients; hyperuricemia & precipitated gout attacks; electrolyte imbalances including hypochloraemic alkalosis, hyponatremia, & hypokalemia; anorexia, gastric irritation, vomiting, sialadenitis, photosensitivity reactions, orthostatic hypotension, paraesthesia & yellow vision; hypersensitivity reactions including skin rashes, fever, pulmonary edema, pneumonitis, anaphylaxis & TEN; cholestatic jaundice, pancreatitis & blood dyscrasias.
Drug Interactions
Hydrochlorothiazide: Potentiation of orthostatic hypotension may occur w/ alcohol, barbiturates or narcotics. May require dose adjustment of concomitant antidiabetics (oral agents & insulin). Additive effects or potentiation w/ other antihypertensives. Impaired absorption w/ cholestyramine & colestipol resins (anionic exchange resins). Intensified electrolyte depletion particularly hypokalemia w/ corticosteroids, ACTH. Possible decreased response to pressor amines eg, norephinephrine. Possible increased responsiveness to nondepolarizing skeletal muscle relaxants (eg, tubocurarine). Reduced renal clearance & added high risk of toxicity of lithium. Diuretic, natriuretic & antihypertensive effects may be reduced w/ NSAIDs.
MIMS Class
Angiotensin II Antagonists / Diuretics
ATC Classification
C09DA03 - valsartan and diuretics ; Belongs to the class of angiotensin II receptor blockers (ARBs) in combination with diuretics. Used in the treatment of cardiovascular disease.
Presentation/Packing
Form
Torval H 80/12.5 FC tab
Packing/Price
30's (P780/box)
Form
Torval H 160/12.5 FC tab
Packing/Price
30's (P1,258.93/box)