Disartan 5 mg+20 mg

Indications
Disartan is used to treat hypertension, either alone or in combination with other antihypertensive medications, to help lower blood pressure. It is particularly beneficial as an initial treatment in patients who are likely to require multiple antihypertensive agents to reach their target blood pressure. The decision to use combination therapy as an initial approach should be personalized, considering factors such as the patient’s baseline blood pressure, the desired target goal, and the increased likelihood of achieving the target with combination therapy as compared to monotherapy. Blood pressure goals may vary depending on the individual patient’s risk.
Take the medicine as prescribed by a registered physician.

Pharmacology
Amlodipine is a dihydropyridine calcium channel blocker that prevents the influx of calcium ions into vascular smooth muscle and cardiac muscle. It predominantly affects vascular smooth muscle more than cardiac muscle. Amlodipine works as a peripheral vasodilator, directly relaxing vascular smooth muscle, which lowers peripheral vascular resistance and blood pressure.

Angiotensin II, formed from angiotensin I by the enzyme angiotensin-converting enzyme (ACE), is a potent vasoconstrictor and plays a crucial role in hypertension. It also stimulates aldosterone secretion by the adrenal glands.

Olmesartan Medoxomil works by blocking the effects of angiotensin II, including its vasoconstrictor and aldosterone-secreting actions. It does so by selectively binding to the AT1 receptor found in various tissues like the vascular smooth muscle and adrenal glands. Studies show that Olmesartan Medoxomil is a reversible, competitive inhibitor of the AT1 receptor. It does not inhibit ACE, the enzyme that converts angiotensin I to angiotensin II.

Dosage & Administration
Patients previously on individually adjusted doses of Amlodipine and Olmesartan Medoxomil may switch to this combination treatment. The dose may also be increased with additional amounts of Amlodipine, Olmesartan Medoxomil, or both as necessary.

• Initial therapy: Start with 5/20 mg once daily for 1 to 2 weeks. The dosage can be increased as needed, up to a maximum of 10/40 mg once daily.
• For elderly patients, especially those aged 75 years and older, the recommended starting dose for Amlodipine is 2.5 mg due to decreased clearance. As the lowest dose for the combination is 5/20 mg, it is not recommended for initial therapy in patients over 75 years old.
  Take the medicine as prescribed by a registered physician.

Interactions
The antihypertensive effect of Olmesartan Medoxomil may be weakened by NSAIDs, including selective COX-2 inhibitors. It is important to monitor blood pressure, renal function, and electrolyte levels in patients who are on this combination therapy, particularly if they are taking other medications that affect the Renin-Angiotensin System (RAS).

Contraindications
This medication should not be used in combination with Aliskiren in patients who have diabetes.

Side Effects
Common side effects include peripheral edema, headache, flushing, and dizziness. Gastrointestinal issues such as sprue-like enteropathy have also been reported.

Pregnancy & Lactation

• Pregnancy Category D: This combination should not be used during the second and third trimesters of pregnancy as it may cause fetal harm, including fetal death. If pregnancy is detected, discontinue the medication immediately.
• It is unknown whether Olmesartan and Amlodipine are excreted in human breast milk. Due to potential adverse effects on a nursing infant, a decision should be made whether to stop breastfeeding or discontinue the drug, considering the importance of the medication for the mother.

Precautions & Warnings

• Use this combination with caution in patients who have:
  • Hypotension, particularly in those who are volume- or salt-depleted.
  • Severe aortic stenosis, as it may cause vasodilation.
  • Severe obstructive coronary artery disease, where it may increase the frequency, duration, or severity of angina or acute myocardial infarction (MI).

Use in Special Populations

• Pediatric Use: The safety and effectiveness in pediatric patients have not been established.
• Geriatric Use: No significant differences in safety or effectiveness were observed between elderly patients (aged 65 and older) and younger adults.
• Renal Impairment: No specific studies have been conducted in patients with renal impairment.
• Hepatic Impairment: Not recommended for initial therapy in patients with liver impairment.

Overdose Effects
There is no available information on the effects of overdose in humans.

Therapeutic Class
Combined antihypertensive preparations.

Storage Conditions
Store at a temperature not exceeding 30°C. Keep the medication away from light and out of the reach of children.

Packaging

• Disartan 5 mg Tablet (3 x 14)