Hipre5 mg

Hypertension

Hipre 5 mg is established (FDA-approved) for the treatment of hypertension, used alone or in combination with other antihypertensive agents, to lower blood pressure in adults and in children 6 years of age and older.

Chronic Stable Angina

Hipre 5 mg is established for the treatment of chronic stable angina, used alone or in combination with other anti-anginal agents, to reduce the frequency of angina episodes.

Vasospastic (Prinzmetal's) Angina

Hipre 5 mg is established for the treatment of confirmed or suspected vasospastic (Prinzmetal's variant) angina.

Coronary Artery Disease

Hipre 5 mg is guideline-supported for use in patients with angiographically documented coronary artery disease, to reduce the risk of hospitalization for angina and the need for revascularization procedures, in patients without heart failure or an ejection fraction below 40%.

Each tablet contains Hipre 5 mg (formulated as Hipre 5 mg besilate/besylate) as the active ingredient. In Bangladesh, Hipre 5 mg is available as 2.5 mg, 5 mg, and 10 mg tablets, and is also marketed in fixed-dose combination products with other antihypertensive agents such as valsartan, olmesartan, telmisartan, atenolol, bisoprolol, or benazepril.

Hipre 5 mg is a long-acting calcium channel blocker of the dihydropyridine class, used primarily to treat high blood pressure (hypertension) and certain types of chest pain (angina). It works by relaxing and widening blood vessels, which lowers blood pressure and reduces the heart's workload, and by improving blood flow to the heart muscle in angina. Hipre 5 mg is taken once daily and has a long duration of action, providing smooth, sustained blood pressure control over 24 hours. It is one of the most widely prescribed antihypertensive medicines worldwide and is commonly used both as a single-ingredient tablet and in fixed-dose combinations with other blood pressure medicines.

Calcium Channel Blocker (Dihydropyridine class)

Hipre 5 mg is slowly and almost completely absorbed after oral administration, with peak plasma concentrations reached 6 to 12 hours after dosing; bioavailability is not significantly affected by food. It is extensively (about 90%) metabolized in the liver, mainly via the CYP3A4 pathway, to inactive metabolites, and has a long elimination half-life of approximately 30 to 50 hours, which allows once-daily dosing and results in gradual onset and offset of effect. Steady-state plasma levels are reached after 7 to 8 days of continuous once-daily dosing. Hipre 5 mg is highly protein-bound (about 93%) and is excreted mainly in the urine as metabolites, with a small fraction excreted unchanged.

• Take Hipre 5 mg once daily at approximately the same time each day, with or without food.
• Swallow the tablet whole with a glass of water; do not crush or chew unless your pharmacist confirms it is safe for the specific product you are using.
• Continue taking Hipre 5 mg even if you feel well; hypertension and angina often have no symptoms, and Hipre 5 mg works best when taken consistently.
• Do not stop taking Hipre 5 mg suddenly without consulting your doctor, particularly if you have angina.
• If a dose is missed, take it as soon as remembered unless it is almost time for the next dose; do not double the dose to make up for a missed one.

• Simvastatin: co-administration increases simvastatin exposure and the risk of muscle injury (myopathy/rhabdomyolysis); the simvastatin dose should be limited to 20 mg daily in patients also taking Hipre 5 mg.
• Strong CYP3A4 inhibitors (e.g., clarithromycin, itraconazole, ketoconazole, ritonavir/protease inhibitors): can significantly increase Hipre 5 mg blood levels, raising the risk of hypotension and other dose-related side effects; dose adjustment and closer monitoring may be needed.
• Strong CYP3A4 inducers (e.g., rifampin, St. John's Wort): can reduce Hipre 5 mg plasma levels and blunt its blood-pressure-lowering effect; blood pressure should be monitored if these are used together.
• Tacrolimus and cyclosporine: Hipre 5 mg can increase blood levels of these immunosuppressants, requiring monitoring of drug levels and possible dose adjustment.
• Other antihypertensive agents and drugs that lower blood pressure: combined use with Hipre 5 mg has an additive blood-pressure-lowering effect, which is often intentional in combination therapy but increases the risk of symptomatic hypotension, especially when treatment is started or doses are increased.
• Simvastatin/other statins and grapefruit juice: large quantities of grapefruit juice can modestly increase Hipre 5 mg levels through the same CYP3A4 pathway; routine dietary quantities are not usually a concern, but excessive intake should be avoided.

Common Side Effects

• Swelling of the ankles or feet (peripheral edema), which is dose-related and one of the most common reasons for stopping treatment
• Dizziness or lightheadedness
• Flushing (warmth or redness of the face)
• Headache
• Palpitations or a fast heartbeat
• Fatigue or drowsiness
• Nausea or abdominal discomfort

Less Common or Serious Side Effects (Seek Medical Attention)

• Symptomatic low blood pressure: severe dizziness, fainting, or feeling like you might pass out (see Precautions and Warnings)
• Worsening chest pain or a heart attack, which can rarely occur, particularly when treatment is started or the dose is increased in patients with severe underlying coronary artery disease (see Precautions and Warnings)
• Signs of liver problems: yellowing of the skin or eyes, dark urine, or unusual tiredness
• Gum swelling or overgrowth (gingival hyperplasia) with long-term use; good dental hygiene can help reduce this
• Signs of an allergic reaction: rash, itching, swelling of the face/lips/tongue, or difficulty breathing

Pregnancy

Hipre 5 mg should be used during pregnancy only if clearly needed and if the potential benefit justifies the potential risk to the fetus; a physician should always be consulted before use in pregnancy. Data on Hipre 5 mg use in human pregnancy are limited. Calcium channel blockers, including Hipre 5 mg, are sometimes used cautiously under obstetric and specialist supervision for management of hypertension arising in pregnancy, but this should only be done as directed by a treating physician, with the lowest effective dose and close monitoring.

Breastfeeding

Hipre 5 mg passes into breast milk in small amounts. Because information on effects in nursing infants is limited, a decision should be made, in consultation with a physician, whether to continue breastfeeding or continue/discontinue Hipre 5 mg, taking into account the benefit of breastfeeding and the mother's clinical need for the medicine.

• Symptomatic hypotension: Hipre 5 mg can cause excessive lowering of blood pressure, particularly in patients with severe aortic stenosis, in the elderly, or when combined with other antihypertensive drugs; caution and gradual dose titration are advised in these situations.
• Increased angina or myocardial infarction with dose titration: rarely, patients (particularly those with severe obstructive coronary artery disease) may develop increased frequency, duration, or severity of angina, or acute myocardial infarction, on starting Hipre 5 mg or at the time of a dose increase; this is uncommon but should be reported to a doctor promptly.
• Hepatic impairment: Hipre 5 mg is extensively metabolized by the liver, and elimination is prolonged in patients with hepatic impairment; a lower starting dose (2.5 mg daily) and gradual titration are recommended.
• Elderly patients: clearance of Hipre 5 mg is reduced in older adults, resulting in higher drug exposure; a lower starting dose and careful titration are recommended (see Use in Special Populations).
• Peripheral edema: swelling of the ankles or feet is dose-dependent and more common at higher doses; it is not usually due to fluid retention/heart failure but reflects local blood vessel dilation, though new or worsening swelling should still be reported to a doctor.
• Heart failure: Hipre 5 mg has been studied in patients with New York Heart Association (NYHA) class II-IV heart failure and has not been associated with worsened survival or heart failure morbidity in these studies, but should still be used cautiously and only as directed in patients with significant heart failure.
• Severe aortic stenosis or cardiogenic shock: Hipre 5 mg should be used with particular caution in patients with severe aortic stenosis, cardiogenic shock, or severe hypotension, since further blood pressure lowering could be poorly tolerated in these settings.

Overdose of Hipre 5 mg can cause excessive peripheral vasodilation leading to marked and potentially prolonged hypotension, and reflex tachycardia; shock and death have been reported with substantial overdose. If an overdose of Hipre 5 mg is suspected, seek immediate medical attention or contact a poison control center right away; do not attempt home treatment. Management is supportive and may include close monitoring of cardiac and respiratory function, elevation of the extremities, careful attention to circulating fluid volume, and vasopressor support if needed to maintain vascular tone and blood pressure, under medical supervision. Because Hipre 5 mg is highly protein-bound, hemodialysis is not expected to be of significant benefit.

Store at room temperature (below 30°C), away from light and moisture. Keep out of reach of children.

• Children: Hipre 5 mg's antihypertensive effect has been studied in patients 6 to 17 years of age; safety and efficacy in children under 6 years of age have not been established (see Pediatric Uses and Dosage).
• Elderly patients: clearance of Hipre 5 mg is decreased with advancing age, leading to increased drug exposure; a lower starting dose (2.5 mg daily) with gradual titration is recommended, and patients should be monitored for hypotension.
• Hepatic impairment: Hipre 5 mg is extensively metabolized by the liver; patients with hepatic impairment should be started on a lower dose (2.5 mg daily) and titrated slowly, with close monitoring (see Precautions and Warnings).
• Renal impairment: Hipre 5 mg pharmacokinetics are not significantly affected by renal impairment, so dose adjustment is generally not required based on kidney function alone; Hipre 5 mg is also not effectively removed by dialysis.
• Pregnant and breastfeeding women: see Pregnancy and Lactation for detailed guidance.

Hipre 5 mg is typically used long-term for the ongoing control of hypertension and chronic angina, since these are chronic conditions requiring continuous management rather than short-term treatment. The duration of therapy is determined by the prescribing physician based on blood pressure control, symptom response, and tolerability, with periodic follow-up to reassess the continued need for and dose of Hipre 5 mg. Hipre 5 mg should not be stopped abruptly without medical advice, particularly in patients being treated for angina.

Calcium Channel Blocker - Dihydropyridine derivative

Hipre 5 mg works by inhibiting the transmembrane influx of calcium ions into vascular smooth muscle and cardiac muscle cells through voltage-gated L-type calcium channels. By reducing calcium entry into vascular smooth muscle, Hipre 5 mg causes relaxation (vasodilation) of coronary and peripheral arterioles, which lowers peripheral vascular resistance and blood pressure and improves blood flow and oxygen delivery to the heart muscle, relieving angina. Because it has a long half-life and gradual onset of action, Hipre 5 mg produces smooth, sustained vasodilation with minimal reflex increase in heart rate compared with shorter-acting dihydropyridines.

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Hipre 5 mg's antihypertensive effect has been established in pediatric patients 6 to 17 years of age, based on studies in this age group; the typical dose is 2.5 to 5 mg once daily, and doses above 5 mg daily have not been studied in children. Safety and efficacy of Hipre 5 mg for hypertension in children below 6 years of age, and for angina or coronary artery disease at any pediatric age, have not been established, so use in these situations should only occur under specialist medical direction. As with adults, treatment in children should start at the lower end of the dose range with monitoring of blood pressure and tolerability.