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Telmisartan and Hydrochlorothiazide (Systemic )


VA CLASSIFICATION
Primary: CV408

Commonly used brand name(s): Micardis HCT; Micardis Plus.

Note: For a listing of dosage forms and brand names by country availability, see Dosage Forms section(s).



Category:


Antihypertensive—

Indications

Note: Bracketed information in the Indications section refers to uses that are not included in U.S. product labeling.

Accepted

Hypertension (treatment)—Telmisartan and hydrochlorothiazide combination is indicated for the treatment of mild to moderate hypertension in patients that have failed to achieve the desired antihypertensive effect through monotherapy.{01}{02} The fixed dose combination is not indicated as initial therapy and is reserved for patients in whom treatment with [diuretic or beta-adrenergic blocking agent] monotherapy was ineffective or was associated with unacceptable adverse effects.{01}{02}
—For additional information on initial therapeutic guidelines related to the treatment of hypertension, see Appendix III.


Pharmacology/Pharmacokinetics

Physicochemical characteristics:
Molecular weight—
    Telmisartan: 514.63{01}
    Hydrochlorothiazide: 297.74{01}

Solubility
Telmisartan

   • Practically insoluble in water and in the pH range of 3 to 9
   • Sparingly soluble in strong acid (except insoluble in hydrochloric acid)
   • Soluble in strong base
Hydrochlorothiazide

   • Slightly soluble in water
   • Freely soluble in sodium hydroxide solution
{01}
Mechanism of action/Effect:

Angiotensin II is formed from angiotensin I in a reaction catalyzed by angiotensin-converting enzyme (ACE, kininase II).. Angiotensin II is the principal pressor agent of the renin-angiotensin system, with effects that include vasoconstriction, stimulation of synthesis and release of aldosterone, cardiac stimulation, and renal reabsorption of sodium. Telmisartan blocks the vasoconstrictor and aldosterone secreting effects of angiotensin II by selectively blocking the binding of angiotensin II to the AT1 receptor in many tissues, such as vascular smooth muscle and the adrenal gland. Its action is therefore independent of the pathways for angiotensin II synthesis. Telmisartan does not inhibit ACE (kininase II), and does not affect the response to bradykinin. It does not bind to or block other hormone receptors or ion channels know to be important in cardiovascular regulation.{01}

Hydrochlorothiazide is a thiazide diuretic.The mechanism of the antihypertensive effect of thiazides is not fully understood. However, thiazide{01} diuretics affect the renal tubular mechanisms of electrolyte reabsorption directly increasing the excretion of sodium salt and chloride in approximately equivalent amounts. Indirectly, the diuretic action of hydrochlorothiazide reduces plasma volume, with consequent increases in plasma renin activity, increases in aldosterone secretion, increases in urinary potassium loss, and decreases in serum potassium. The renin-aldosterone link is mediated by angiotensin II, so coadministration of an angiotensin II receptor antagonist tends to reverse the potassium loss associated with these diuretics.{01}

Absorption:

Telmisartan: bioavailability 42and58%, depending on dose (40 mg and 160 mg respectively){01}. Food reduces the bioavailability of telmisartan, reducing area under the plasma concentration–time curve (AUC) by approximately 6% with the 40-mg tablets and by approximately 20% with the 160-mg tablets.{01}

Distribution:

Hydrochlorothiazide crosses the placenta but not the blood brain barrier, and it is distributed in breast milk.{01}


Volume of distribution (Vol D):

Telmisartan: 500 L {01}


Protein binding:

Telmisartan: Very high (>99%), mainlyto albumin and 1-acid glycoprotein.{01}

Biotransformation:

Telmisartan undergoes conjugation to form an inactive acylglucuronide metabolite, the only metabolite identified in human plasma and urine.{01}

Hydrochlorothiazide is not metabolized.{01}

Half-life:

Telmisartan (elimination): 24 hours{01}

Hydrochlorothiazide (plasma): 5.6 to 14.8 hours{01}

Onset of action:

Telmisartan—Within 3 hours after administration of a single dose.{01}{02}

Hydrochlorothiazide—Within 2 hours of oral administration{01}{02}.

Time to peak concentration:

Telmisartan—C max reached in 0.5 to 1 hour

Note: Food slightly decreased the AUC by about 6% and 20% respectively following a 40 mg and 160 mg dose.


Time to peak effect:

Hydrochlorothiazide: 4 hours{01}

Duration of action:

Telmisartan: 24 hours
{01}
Hydrochlorothiazide: 6 to 12 hours{01}

Elimination:
    Telmisartan is primarily fecally eliminated, >97% unchanged{01}.
    Hydrochlorothiazide is eliminated rapidly by the kidney, ³61% is eliminated unchanged within 24 hours.{01}


In Dialysis—
        Telmisartan is not removed by hemofiltration{01}or hemodialysis.{02}



Precautions to Consider

Carcinogenicity

No carcinogenicity studies have been conducted with the combination of telmisartan and hydrochlorothiazide.{01}

There was no evidence of carcinogenicity when telmisartan was administered in the diet to mice and rats for up to 2 years. The highest doses administered to mice, 1000 mg per kg per day, and to rats, 100mg per kg per day, (59 and 13 times, respectively, the maximum recommended human dose (MRHD) of telmisartan). {01}

Two–year feeding studies in mice and rats conducted under the auspices of the National Toxicology Program uncovered no evidence of a carcinogenic potential of hydrochlorothiazide in female mice at doses of 600 mg per kg per day or in the male and female rats at doses of 100 mg per kg per day. The National Toxicology Program, however, found equivocal evidence for hepatocarcinogenicity in male mice.{01}

Mutagenicity

No mutagenicity studies have been conducted with the combination of telmisartan and hydrochlorothiazide.{01}

Genotoxicity assays including bacterial mutagenicity tests with Salmonella and E. coli (Ames), a gene mutation test with Chinese hamster V79 cells, a cytogenetic test with human lymphocytes, and a mouse micronucleus test, did not reveal any telmisartan–related effects at either the gene or chromosome level.
{01}
Hydrochlorothiazide was not genotoxic in vitro in the Ames mutagenicity assay of Salmonella typhimurium strains TA 98, TA 100, TA1535, TA1537, and TA1538 and in the Chinese Hamster Ovary (CHO) test for chromosomal aberrations, or in in vivo assays using mouse germinal cell chromosomes, Chinese Hamster bone marrow chromosomes, and the Drosophila sex–linked recessive lethal trait gene. Positive test results were obtained only in the in vitro CHO sister chromatid exchange assay, in the Mouse Lymphoma Cell assay, and in the Aspergillus nidulans non–disjunction assay{01}.

Pregnancy/Reproduction
Fertility—
No fertility studies have been conducted with the combination of telmisartan and hydrochlorothiazide.{01}

No reproductive performance problems were noted when male and female rats were administered 100 mg per kg per day (13 times the MRHD) of telmisartan.
{01}
Hydrochlorothiazide had no adverse effects on the fertility of mice and rats of either sex in studies wherein these species were exposed , via there diet, to doses of up to 100 and 4 mg per kg respectively, prior to mating and throughout gestation{01}.

Pregnancy—
When pregnancy is detected, telmisartan and hydrochlorothiazide should be discontinued as soon as possible.{01}Thiazides cross the placental barrier and appear in cord blood and create a risk of fetal or neonatal jaundice, thrombocytopenia, and possibly other adverse reactions that have occurred in adults.{01}

In humans the use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy has been associated with fetal and neonatal injury including hypotension, neonatal skull hypoplasia, anuria, reversible or irreversible renal failure and death. Oligohydramnios has also been reported and is associated with fetal limb contractures, craniofacial deformation, and hypoplastic lung development{01}.

No teratogenic effects were observed when telmisartan was administered to pregnant rats and pregnant rabbits at doses of 50 and 45 mg per kg of body weight per day, respectively.{01} In rabbits, embryo lethality associated with maternal toxicity was observed at 45 mg per kg per day (approximately 12 times the maximum recommended human dose (MRHD) of 80 mg based on a mg per m2 basis). In rats, maternally toxic telmisartan doses of 15 mg per kg per day (1.9 times the MRHD) administered during late gestation and lactation were observed to produce adverse effects in neonates, including reduced viability, low birth weight, delayed maturation, and decreased weight gain. Telmisartan has been shown to be present in rat fetuses during late gestation. Rats and rabbits showed no developmental toxicity effects at doses of 5 and 15 mg per kg per day (approximately 0.64 and 3.7 times the MRHD), respectively. Studies in which hydrochlorothiazide was administered to pregnant mice and rats during their respective periods of major organogenesis at doses up to 3000 and 1000 mg per kg per day, respectively provided no evidence of harm to the fetus.{01}

First Trimester: FDA Pregnancy Category C{01}

Second and Third Trimester: FDA Pregnancy Category D{01}

Breast-feeding

It is not known whether telmisartan is distributed in human breast milk. However, telmisartan is distributed into the milk of rats. Because of the potential for adverse effects on the nursing infant, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.{01}

Thiazides are distributed in human milk{01}

Pediatrics

Appropriate studies on the relationship of age to the effects of telmisartan have not been performed in children up to 18 years of age. Safety and efficacy have not been established.{01}


Geriatrics


Appropriate studies performed to date have not demonstrated geriatrics–specific problems that would limit the usefulness of telmisartan and hydrochlorothiazide combination in the elderly.{01}


Pharmacogenetics

Females generally have twofold to threefold higher plasma concentrations of telmisartan than males{01}. However, there is no significant increase in blood pressure response or in the incidence of orthostatic hypotension in females. No adjustment in dosage is necessary. The overall response to the combination was similar for black and non-black patients.{02}

Drug interactions and/or related problems
The following drug interactions and/or related problems have been selected on the basis of their potential clinical significance (possible mechanism in parentheses where appropriate)—not necessarily inclusive (» = major clinical significance):


Note: Combinations containing any of the following medications, depending on the amount present, may also interact with this medication.


For telmisartan only{01}
Digoxin    (concurrent use with telmisartan has resulted in median increases in digoxin peak plasma concentrations of 49% and in trough concentrations of 20%; digoxin plasma concentrations should be monitored when initiating, adjusting, and discontinuing telmisartan)

{01}
Warfarin    (concurrent use with telmisartan for a period of 10 days has resulted in a slight decrease in the mean warfarin trough plasma concentration; however this did not result in a change in international normalized ratio [INR])

{01}
For hydrochlorothiazide only{01}
» Alcohol or
» Barbiturates or
» Narcotics    (may potentiate orthostatic hypotension)

{01}
» Antidiabetic agents, oral or
» Insulin    (dosage adjustments may be needed)

{01}
» Cholestyramine resin or
» Colestipol resin    (absorption of hydrochlorothiazide is impaired in the presence of anionic exchange resins. Single doses of both cholestyramine and colestipol resins bind the hydrochlorothiazide and reduces its absorption from the gastrointestinal tract by up to 85% and 43% respectively)

{01}
Corticosteroids or
Corticotropin    (intensifies electrolyte depletion{01})


» Diuretics, others    (to minimize the incidence of hypotension, caution should be used with patients whose renin–angiotensin system is activated by vigorous treatment with diuretics)

{01}
» Lithium    (may reduce the renal clearance of lithium and add a high risk of lithium toxicity; concurrent use generally is not recommended)

{01}
Nonsteroidal anti-inflammatory drugs (NSAIDS)    (may reduce the diuretic, natriuretic, and antihypertensive effects hydrochlorothiazide; the patient should be closely observed during concurrent use to ensure that the desired effect of the diuretic is being obtained)

{01}
Other antihypertensive drugs    (may produce an additive effect when used concomitantly)

{01}
Pressor amines    (possible decreased response to pressure amines, butnot sufficient topreclude their use.{01})


Skeletal muscle relaxants, nondepolarizing    (possible increased responsiveness to the muscle relaxant)

{01}

Laboratory value alterations
The following have been selected on the basis of their potential clinical significance (possible effect in parentheses where appropriate)—not necessarily inclusive (» = major clinical significance):

With physiology/laboratory test values
Alanine aminotransferase (ALT [SGPT]){01} and
Aspartate aminotransferase (AST [SGOT]) {01} and
Bilirubin, serum{01}    (elevations of liver enzymes and/or serum bilirubin have occurred. No telmisartan/hydrochlorthiazide-treated patients discontinued therapy due to abnormal hepatic function)

{01}
Blood urea nitrogen (BUN) {01} and
Creatinine serum{01}    (increases in BUN and serum creatinine values of approximately 11.2 mg/dL and 0.5 mg/dL were observed in 2.8% and 1.4% of hypertensive patients respectively; no patient discontinued treatment due to the increases)

{01}
Hemaglobin concentration{01}and
Hematocrit value{01}    (decreases in hemoglobin and hematocrit of approximately 2 grams/dL and 9% were observed in 1.2% and 0.6% of patients respectively; however, these changes were not considered clinically significant, and no patient discontinued due to anemia)

{01}
For hydrochlorothiazide only{01}
Calcium    (may decrease urinary calcium excretion and cause intermittent and slight elevation of serum calcium; hypercalcemia may be evidence of hidden hyperparathyroidism; thiazides should be discontinued prior to performing parathyroid function tests)

{01}
Chloride    (concentrations may be decreased; however, deficits are generally mild and do not require special treatment)

{01}
Cholesterol or
Triglycerides, serum    (concentrations may be increased)

{01}
» Glucose    (concentrations may be increased or latent diabetes mellitus may become manifest; dosage adjustment of antidiabetic medications may be required)

{01}
Magnesium    (concentrations may be decreased due to increase in urinary excretion)

{01}
Potassium    (concentrations may be decreased during thiazide therapy)

    (no patient treated with 40/12.5 mg or 80/12.5 mg of telmisartan/hydrochlorothiazide combination had a decrease in potassium concentration more than 1.4 mEq/L )


Sodium    ( concentrations may be decreased in edematous patients in hot weather)

{01}
Uric acid    (concentrations may be increased or frank gout may be precipitated)

{01}
Medical considerations/Contraindications
The medical considerations/contraindications included have been selected on the basis of their potential clinical significance (reasons given in parentheses where appropriate)— not necessarily inclusive (» = major clinical significance).


Except under special circumstances, this medication should not be used when the following medical problem exists:
» Anuria or{01}
» Hypersensitivity to any other sulfonamide–derived drugs{01}
» Hypersensitivity to telmisartan and hydrochlorothiazide or any of its components{01}
Risk-benefit should be considered when the following medical problems exist
Allergy, history of or
Bronchial asthma, history of    (hypersensitivity reactions to hydrochlorothiazide are more likely to occur in patients with a history of allergy or bronchial asthma)

{01}
Diabetes mellitus    (concomitant use of thiazide diuretics may require a dosage adjustment of insulin or oral hypoglycemic agents; latent diabetes may become manifest during thiazide therapy)

{01}
» Biliary obstructive disorders or
» Hepatic insufficiency or
» Liver disease, progressive    (plasma concentrations of telmisartan may be increased and absolute bioavailability may reach 100%; thiazide diuretics should be used with caution because minor alterations of fluid and electrolyte balance may precipitate hepatic coma )

{01}
» Congestive heart failure, severe    (therapy with angiotensin-converting enzyme [ACE] inhibitors and angiotensin receptor antagonists in these patients, who may be especially susceptible to changes in the renin-angiotensin-aldosterone system, has been associated with oliguria, azotemia, acute renal failure, and/or death)

{01}
Intravascular volume depletion or
Sodium depletion    (to decrease risks of hypotension, therapy should be initiated cautiously with patients whose renin-angiotensin system has been activated)

    (conditions should be corrected prior to administration of medication)

    (treatment should be started under close medical supervision)

{01}
» Lupus erythematosus, systemic    (may be exacerbated or activated by use of thiazide diuretics)

{01}
» Renal function impairment    (thiazide diuretics may precipitate azotemia; caution is recommended in patients with severe renal function impairment; thiazide diuretics, and therefore the combination, are not recommended in patients whose creatinine clearance is < 30 mL per minute)

{01}
Sympathectomy    (antihypertensive effects may be enhanced)

{01}

Patient monitoring
The following may be especially important in patient monitoring (other tests may be warranted in some patients, depending on condition; » = major clinical significance):

» Electrolytes, serum and urine    (all patients receiving thiazide therapy should be observed for signs of fluid or electrolyte imbalance including: hyponatremia, hypochloremic alkalosis, and hypokalemia; determinations are particularly important when patients experience excessive vomiting or receive parenteral fluids)

{01}


Side/Adverse Effects
The following side/adverse effects have been selected on the basis of their potential clinical significance (possible signs and symptoms in parentheses where appropriate)—not necessarily inclusive:

Those indicating need for medical attention
Incidence less frequent
    
Hypokalemia (convulsions; decreased urine; dry mouth; irregular heartbeat; increased thirst; loss of appetite; mood changes; muscle pain or cramps; nausea or vomiting; numbness or tingling in hands, feet, or lips; shortness of breath; unusual tiredness or weakness){01}
    
hypotension {01}(blurred vision; confusion; dizziness; faintness, or lightheadedness when getting up from a lying or sitting position sudden sweating; unusual tiredness or weakness)
    
tachycardia (fainting; fast, pounding, or irregular heartbeat, or pulse palpitations){01}
    
urinary tract infection (difficulty in urinating; frequent urge to urinate; painful urination){01}

Incidence rare
    
Angioedema (large; hive-like swelling on face; eyelids; lips; tongue; throat; hands; legs; feet; sex organs)— single case reported among 3781 patients treated with telmisartan{01}



Those indicating need for medical attention only if they continue or are bothersome
Incidence more frequent
    
Dizziness {01}
    
upper respiratory tract infection ( cough; runny or stuffy nose; sore throat){01}
{01}
Incidence less frequent
    
Abdominal pain {01}
    
back pain {01}
    
bronchitis ( cough producing mucus, difficulty breathing, shortness of breath, chest tightness ){01}
    
cough {01}
    
diarrhea {01}
    
dyspepsia (acid or sour stomach, belching, heartburn, indigestion, or stomach discomfort upset or pain){01}
    
fatigue
    
headache {01}
    
influenza-like symptoms {01}(chills; cough; diarrhea; fever; general feeling of discomfort or illness; headache; joint pain; loss of appetite; muscle aches and pains; nausea; runny nose; shivering; sore throat; sweating; trouble sleeping; unusual tiredness or weakness; vomiting)
    
nausea {01}
    
pain {01}
    
pharyngitis (dryness or soreness of throat, fever, hoarseness, tender, swollen glands in neck, trouble in swallowing, or voice changes){01}
    
rash {01}
    
sinusitis ( pain or tenderness around eyes and cheekbones, fever, stuffy or runny nose, headache, cough){01}
    
vomiting {01}





Overdose
For more information on the management of overdose or unintentional ingestion, contact a poison control center (see Poison Control Center Listing).

Clinical effects of overdose
The following effects have been selected on the basis of their potential clinical significance (possible signs and symptoms in parentheses where appropriate)—not necessarily inclusive:
Telmisartan
    
Bradycardia (slow or irregular heartbeats; lightheadedness)—could occur as a result of parasympathetic stimulation
    
dizziness {01}
    
hypotension {01}
    
tachycardia (fast, pounding, or irregular heartbeat or pulse ){01}

Hydrochlorothiazide
    
Dehydration
    
hypochloremia (increased thirst; loss of appetite){01}
    
hypokalemia (convulsions; decreased urine; dry mouth; irregular heartbeat; increased thirst; loss of appetite; mood changes; muscle pain or cramps; nausea or vomiting; numbness or tingling in hands, feet, or lips; shortness of breath; unusual tiredness or weakness){01}
    
hyponatremia (coma; confusion; convulsions; decreased urine output; dizziness; fast or irregular heartbeat; headache; increased thirst; muscle pain or cramps; nausea or vomiting; shortness of breath; swelling of face, ankles, or hands; unusual tiredness or weakness){01}


Treatment of overdose


Specific treatment:
Telmisartan is not removed by hemodialysis.{01}

The degree to which hydrochlorothiazide is removed by hemodialysis has not been established.{01}

Treatment should be symptomatic and supportive{01}



Patient Consultation
As an aid to patient consultation, refer to Advice for the Patient, Telmisartan and Hydrochlorothiazide (Systemic).
In providing consultation, consider emphasizing the following selected information (» = major clinical significance):

Before using this medication
»   Conditions affecting use, especially:
Hypersensitivity to telmisartan and hydrochlorothiazide or any of its components

Hypersensitivity to any other sulfonamide-derived drugs

Pregnancy—When used during the second and third trimesters, drugs that act directly on the renin-angiotensin system can cause injury and even death to the developing fetus. When pregnancy is detected, telmisartan and hydrochlorothiazide should be discontinued as soon as possible.

Thiazides cross the placental barrier and appear in core blood. There is a risk of fetal or neonatal jaundice, thrombocytopenia, other adverse effects seen in adults.





Breast-feeding—It is not known whether telmisartan is distributed in human breast milk. However, telmisartan is distributed into the milk of rats. Because of the potential for adverse effects on the nursing infant, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother. Hydrochlorothiazide is distributed in breast milk.
Other medications, especially alcohol, barbiturates, diuretics, lithium, and narcotics
Other medical problems, especially anuria,, severe congestive heart failure, systemic lupus erythematosus, renal function impairment and hepatic insufficiency

Proper use of this medication
» Compliance with therapy; taking medication at the same time each day to maintain the antihypertensive effect

Possible need for control of weight and diet, especially sodium intake; risks associated with sodium depletion; not taking potassium supplements or salt substitutes containing potassium unless approved by physician.

» Importance of taking medication even if feeling well; possible life-long therapy; checking with physician before discontinuing medication.

Medication may be taken with or without food.

» Proper dosing
Missed dose: Taking as soon as possible; not taking if almost time for next scheduled dose; not doubling doses

Proper storage

Precautions while using this medication
Visiting the physician regularly to check progress

» Notifying physician immediately if pregnancy is suspected

Not taking other medications without consulting the physician

Caution when driving, using machines, or doing other things that may be dangerous if dizziness, light-headedness or drowsiness occur while taking telmisartan and hydrochlorothiazide

To prevent dehydration and hypotension, checking with physician if severe nausea, vomiting, or diarrhea occurs and continues

» Caution should be taken when standing from a lying or sitting position.

Caution when exercising or during exposure to hot weather, because of the risk of dehydration and hypotension due to reduced fluid volume

Diabetics: May increase blood sugar levels


Side/adverse effects
Signs of potential side effects, especially angioedema, hypokalemia, tachycardia, urinary tract infection.


General Dosing Information
May be administered with other antihypertensive agents{01}.

The use of telmisartan should normally be reserved for patients on whom treatment with diuretic of beta–blocker monotherapy was ineffective or was associated with unacceptable adverse effects. {01}

Diet and Nutrition
Food slightly reduces the bioavailability of telmisartan.Telmisartan and hydrochlorothiazide combination may be administered with or without food.{01}{02} However, it should be take consistently with regard to food intake.{02}


Oral dosage forms

TELMISARTAN AND HYDROCHLOROTHIAZIDE TABLETS

Usual Adult Dose
Antihypertensive
Oral, initially one tablet containing 40 mg of telmisartan and 12.5 mg of hydrochlorothiazide once daily.
{01}
Note: The fixed dose combination is not indicated for initial therapy.{01}{02}



Usual adult prescribing limits
160 mg of telmisartan and 25 mg of hydrochlorothiazide once daily{01}.

Usual Pediatric Dose
Antihypertensive
Safety and efficacy have not been established. {01}


Usual Geriatric Dose
See Usual adult dose.

Usual geriatric prescribing limits
See Usual adult prescribing limits.

Strength(s) usually available
U.S.—


40 mg of telmisartan and 12.5 mg of hydrochlorothiazide (Rx) [Micardis HCT (iron oxide red) ( lactose monohydrate) (magnesium stearate) (maize starch) (meglumine) (microcrystalline cellulose) (povidone ) (sodium hydroxide) ( sodium starch glycolate) (sorbitol)]{01}


80 mg of telmisartan and 12.5 mg of hydrochlorothiazide (Rx) [Micardis HCT (iron oxide red) (lactose monohydrate) (magnesium stearate ) (maize starch) (meglumine ) (microcrystalline cellulose) ( povidone) (sodium hydroxide) ( sodium starch glycolate) (sorbitol)]{01}

Canada—


80 mg of telmisartan and 12.5 mg of hydrochlorothiazide (Rx) [Micardis Plus (iron oxide red) ( lactose monohydrate) (magnesium stearate) (maize starch) (meglumine) (microcrystalline cellulose) (povidone ) (sodium hydroxide) ( sodium starch glycolate) (sorbitol)]{02}

Packaging and storage:
Store between 25 °C (77 °F); excursions permitted between 15 and 30°C (59 and 86°F). Protect from moisture.{01}{02}

Tablets should not be removed from blisters until immediately before administration.

Auxiliary labeling:
May be administered with or without food.{01}{02}



Developed: 02/21/2002
Revised: 06/13/2002



References
  1. Product Information: Micardis® HCT, telmisartan and hydrochlorothiazide. Boehringer Ingelheim, Ridgefield, Connecticut. (PI revised 11/2000) reviewed 11/2001.
  1. Product Information: Micardis® Plus, telmisartan and hydrochlorothiazide. Boehringer Ingelheim, Burlington, Ontario. (PI revised 08/2001) reviewed 11/2001.
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