• Initiate a patient whose blood pressure is not adequately controlled with telmisartan monotherapy 80 mg on Telmisartan and Hydrochlorothiazide tablets, 80 mg/12.5 mg once daily. Dose can be titrated up to 160 mg/25 mg after 2 to 4 weeks, if necessary.
• Initiate a patient whose blood pressure is not adequately controlled by 25 mg once daily of hydrochlorothiazide, or is controlled but who experiences hypokalemia with this regimen on Telmisartan and Hydrochlorothiazide tablets 80 mg /12.5 mg once daily. Dose can be titrated up to 160 mg/25 mg after 2 to 4 weeks, if necessary.
• Patients titrated to the individual components (Telmisartan and Hydrochlorothiazide) may instead receive the corresponding dose of Telmisartan and Hydrochlorothiazide tablets.
• Telmisartan and Hydrochlorothiazide tablets may be administered with other antihypertensive drugs.

Dose Adjustment for Hepatic Impairment

• Initiate patients with biliary obstructive disorders or hepatic insufficiency under close medical supervision using the 40 mg/12.5 mg combination. Telmisartan and Hydrochlorothiazide tablets are not recommended for patients with severe hepatic impairment [see Use in Specific Populations and Clinical Pharmacology].

Telmisartan and Hydrochlorothiazide tablets are contraindicated:

• In patients who are hypersensitive to any component of this product [see Warnings and Precautions .
• In patients with anuria.
• For co-administration with aliskiren in patients with diabetes.

Fetal Toxicity: Telmisartan

Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death. Resulting oligohydramnios can be associated with fetal lung hypoplasia and skeletal deformations.

Hydrochlorothiazide

Thiazides cross the placental barrier and appear in cord blood. Adverse reactions include fetal or neonatal jaundice and thrombocytopenia [see Use in Specific Populations.

Hypotension in Volume- or Salt-Depleted Patients

In patients with an activated renin-angiotensin system, such as volume- or salt-depleted patients (e.g., those being treated with high doses of diuretics), symptomatic hypotension may occur after initialization of treatment with Telmisartan and Hydrochlorothiazide tablets. Correct volume or salt depletion prior to administration of Telmisartan and Hydrochlorothiazide tablets.

Electrolytes and Metabolic Disorders

Drugs, including telmisartan, that inhibit the renin-angiotensin system can cause hyperkalemia, particularly in patients with renal insufficiency, diabetes, or combination use with other angiotensin receptor blockers or ACE inhibitors and the concomitant use of other drugs that raise serum potassium levels.

Hydrochlorothiazide can cause hypokalemia and hyponatremia. Thiazides have been shown to increase the urinary excretion of magnesium; this may result in hypomagnesemia. Hypomagnesemia can result in hypokalemia which may be difficult to treat despite potassium repletion. Monitor serum electrolytes periodically.

• Bladder Pain.
• Decreased Urine.
• Dizziness, Faintness, Or Lightheadedness When Getting Up from A Lying or Sitting Position.
• Fast, Pounding, Or Irregular Heartbeat or Pulse.
• Increased Thirst.
• Muscle Pain or Cramps.
• Nausea Or Vomiting.

Store at room temperature.

TELMI H: 10×10’s