- Approval Id
- 50166eabcf4ff612
- Drug Name
- TANATRIL TABLETS 5 MG
- Product Name
- TANATRIL TABLETS 5 MG
- Approval Number
- SIN10615P
- Approval Date
- 1999-01-06
- Registrant
- TANABE PHARMA SINGAPORE PTE. LTD.
- Licence Holder
- TANABE PHARMA SINGAPORE PTE. LTD.
- Drug Type
- Therapeutic
- Forensic Classification
- PRESCRIPTION ONLY MEDICINES
- Dosage Form
- TABLET
- Dosage
- <p><strong>DOSAGE AND ADMINISTRATION</strong><br>
The usual adult dosage for oral use is 5mg to 10mg of imidapril hydrochloride once a day. The dosage may be adjusted depending on the patient’s age and symptoms. In patients with severe hypertension, hypertension with renal impairment, or renal parenchymal hypertension, the recommended initial dose is 2.5 mg once a day.</p>
<p><strong>< Precautions ></strong><br>
In patients with serious renal impairment whose creatinine clearance levels are less than 30mL/ min. or serum creatinine levels are greater than 3 mg/dL, the drug should be administered with care; consider decreasing the usual dosage to the half or prolonging the time interval between administrations. [Excessive hypotension or further decrease in renal function may occur due to decrease in urinary excretion rate.] (See PRECAUTIONS – Careful Administration and PHARMACOKINETIC – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>.)</p>
- Route Of Administration
- ORAL
- Indication Info
- <p><strong>INDICATIONS</strong><br>
Hypertension. Renal parenchymal hypertension.</p>
- Contraindications
- <p><strong>CONTRAINDICATIONS (TANATRIL is contraindicated in the following patients.)</strong></p>
<ol class="decimalparen">
<li>Patients with a history of hypersensitivity to any of the ingredients of the drug.</li>
<li>Patients with a history of angioedema (Angioedema due to drug such as angiotensin converting enzyme (ACE) inhibitors, etc., hereditary angioedema, acquired angioedema, idiopathic angioedema, etc.) [Angioedema associated with dyspnea may occur.]</li>
<li>Patients undergoing apheresis by an adsorber using dextran sulfate immobilized cellulose, tryptophan immobilized poly-vinyl alcohol or polyethylene terephthalate [shock may occur.] (See PRECAUTIONS – “Drug Interactions” section – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>.)</li>
<li>Patients who undergo hemodialysis with acrylonitrile methallyl sulfonate sodium membrane (AN69®) [Anaphylactoid symptom may occur.] (See PRECAUTIONS – Drug Interactions – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>.)</li>
<li>Pregnant women or women who may possibly be pregnant. [See PRECAUTIONS – Use in Patients with Reproductive Potential – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>.]</li>
<li>Patients with diabetes mellitus or renal impairment (GFR < 60 ml/min/1.73 m<sup>2</sup>) being treated with aliskiren fumarate (excluding patients with markedly uncontrolled blood pressure even after antihypertensive treatment with other drugs) [Increased risk for nonfatal stroke, renal impairment, hyperkalemia, and hypotension have been reported.] (See “Important Precautions” section – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>.)</li>
<li>Patients receiving sacubitril valsartan sodium hydrate or patients within 36 hours of discontinuation of the drug [Angioedema may occur.] (See “Drug Interactions” section – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>)</li>
</ol>
- Atc Code
- C09AA16
- Atc Item Name
- imidapril
- Pharma Manufacturer Name
- MITSUBISHI TANABE PHARMA SINGAPORE PTE. LTD.
