Candalkan Plus 

 Candesartan cilexetil+ Hydrochlorothiazide 16/12.5 mg Film Coated Tablets.

 Candesartan cilexetil+ Hydrochlorothiazide 32/12.5 mg Tablets. 

 

Usage and indications:

Candalkan plus is indicated for the treatment of hypertension. This fixed dose combination is not indicated for initial therapy.

Dosage and administration:

  • The usual recommended starting dose of candesartan cilexetil is 16 mg once daily when it is used as monotherapy in patients who are not volume depleted. Candalkan can be administered once or twice daily with total daily doses ranging from 8 mg to 32 mg. Patients requiring further reduction in blood pressure should be titrated to 32 mg, Doses larger than 32 mg do not appear to have a greater blood pressure lowering effect.
  • Hydrochlorothiazide is effective in doses of 12.5 to 50 mg once daily.
  • To minimize dose-independent side effects, it is usually appropriate to begin combination therapy only after a patient has failed to achieve the desired effect with monotherapy.

Undesirable effects:

Body as a Whole:

inflicted injury, fatigue, pain, chest pain, peripheral edema, and asthenia. 

Central /Peripheral Nervous System:  

vertigo, paraesthesia, hypesthesia.

Respiratory System Disorders:

bronchitis, sinusitis, pharyngitis, coughing, rhinitis, dyspnea.

Musculoskeletal System Disorders:

arthralgia, myalgia, arthrosis, arthritis, leg cramps, sciatica.

Gastrointestinal System Disorders:

nausea, abdominal pain, diarrhea, dyspepsia, gastritis, gastroenteritis, vomiting.

Metabolic and Nutritional Disorders:

hyperuricemia, hyperglycemia, hypokalemia, increased BUN, creatine phosphokinase increased.

Urinary System Disorders:

urinary tract infection, hematuria, cystitis.

Liver/Biliary System Disorders:

hepatic function abnormal, increased transaminase levels.

Heart Rate and Rhythm Disorders:  

tachycardia, palpitation, extrasystoles, bradycardia.

Psychiatric Disorders:

depression, insomnia, anxiety.

Cardiovascular Disorders:

ECG abnormal.

Skin and Appendages Disorders:

eczema, sweating increased, pruritus, dermatitis, rash.    

Platelet/Bleeding-Clotting Disorders:

epistaxis.

Resistance Mechanism Disorders:

infection, viral infection.

Vision Disorders:  

conjunctivitis

Hearing and Vestibular Disorders:

tinnitus.

Warnings and precautions:

Dual blockade of the rennin-angiotensin-aldosteron system (RAAS)

There is evidence that the concomitant use of ACE-inhibitors, angiotensin II receptor blockers    or Aliskirin increase the risk of hypotension. Hyperkalemia and decreased renal function (include acute renal failure). Dual blockade of RAAS through the combined use of ACE-inhibitors.  Angiotensin II receptor blockers or Aliskiren is therefore not recommended.

If dual blockade therapy is considered absolutely necessary. This should only occur under specialist supervision and subject to frequent close monitoring of renal function. Electrolytes and blood pressure. ACE-inhibitors and angiotensin II receptor blockers should not be used concomitantly in patients with diabetic nephropathy.

Candalkan plus not used during pregnancy as it can cause injury and death to the developing fetus:

Use of drugs that act on the renin-angiotensin system during 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. Potential neonatal adverse effects include skull hypoplasia, anuria, hypotension, renal failure, and death. When pregnancy is detected, discontinue Candalkan plus as soon as possible.

Hypotension in Volume- and Salt-Depleted Patients:

Initiation of antihypertensive therapy may cause symptomatic hypotension in patients with intravascular volume- or sodium- depletion These conditions should be corrected prior to administration of, Candalkan plus or the treatment should start under close medical supervision .

If hypotension occurs, the patients should be placed in the supine position and, if necessary, given an intravenous infusion of normal saline. A transient hypotensive response is not a contraindication to further treatment which usually can be continued without difficulty once the blood pressure has stabilized:

Acute Myopia and Secondary Angle-Closure Glaucoma:

Hydrochlorothiazide can cause an idiosyncratic reaction, resulting in acute transient myopia and acute angle-closure glaucoma Symptoms include acute onset of decreased visual acuity or ocular pain and typically occur within hours to weeks of drug initiation. Untreated acute angle-closure glaucoma can lead to permanent vision loss. The primary treatment is to discontinue hydrochlorothiazide as rapidly as possible. Prompt medical or surgical treatments may need to be considered if the intraocular pressure remains uncontrolled. Risk factors for developing acute angle-closure glaucoma may include a history of sulfonamide or penicillin allergy.

Impaired Hepatic Function:

Thiazide diuretics should be used with caution in patients with impaired hepatic function or progressive liver disease, since minor alterations of fluid and electrolyte balance may precipitate hepatic coma.

Hypersensitivity Reaction:

Hypersensitivity reactions to hydrochlorothiazide may occur in patients with or without a history of allergy or bronchial asthma.

Systemic Lupus Erythematosus:

Thiazide diuretics have been reported to cause exacerbation or activation of systemic lupus erythematosus.

Lithium Interaction:  

Lithium generally should not be given with thiazides.

Pack: box of 7 or 14 tablets.

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