Protace-H
Generic Name
Ramipril + Hydrochlorothiazide
Manufacturer
ACI Limited
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| protace h 25 mg tablet | ৳ 5.00 | ৳ 50.00 |
Description
Overview of the medicine
Protace-H 25 mg Tablet is a combination medication used to treat high blood pressure (hypertension). It contains Ramipril, an ACE inhibitor, and Hydrochlorothiazide, a thiazide diuretic, which work together to lower blood pressure effectively.
Uses & Indications
Dosage
Adults
Usually 1 tablet once daily. Dosage may be adjusted based on individual response and tolerability.
Elderly
Initiate with a lower dose and titrate cautiously, monitoring renal function and electrolytes.
Renal_impairment
Dosage adjustment is necessary in patients with renal impairment; monitor creatinine and potassium closely. Not recommended in severe renal impairment (CrCl <30 mL/min).
How to Take
Take orally, once daily, preferably in the morning. May be taken with or without food. Swallow the tablet whole with water.
Mechanism of Action
Ramipril inhibits the angiotensin-converting enzyme (ACE), preventing the conversion of angiotensin I to angiotensin II, a potent vasoconstrictor. This leads to vasodilation, reduced aldosterone secretion, and decreased blood pressure. Hydrochlorothiazide acts on the distal convoluted tubule of the kidney to inhibit sodium and chloride reabsorption, increasing the excretion of water, sodium, and chloride, thus lowering blood volume and blood pressure.
Pharmacokinetics
Onset
Ramipril: 1-2 hours (antihypertensive effect). Hydrochlorothiazide: 2 hours (diuretic effect).
Excretion
Ramiprilat is primarily excreted via the kidneys. Hydrochlorothiazide is eliminated predominantly by renal excretion.
Half life
Ramiprilat: 13-17 hours (effective half-life). Hydrochlorothiazide: 5.6-14.8 hours.
Absorption
Ramipril is rapidly absorbed and hydrolyzed to ramiprilat. Bioavailability of ramiprilat is about 28%. Hydrochlorothiazide is rapidly absorbed from the gastrointestinal tract, with a bioavailability of 65-75%.
Metabolism
Ramipril is extensively metabolized in the liver to its active metabolite ramiprilat and inactive metabolites. Hydrochlorothiazide is not metabolized and is excreted unchanged.
Side Effects
Contraindications
- History of angioedema related to previous ACE inhibitor treatment
- Hereditary or idiopathic angioedema
- Pregnancy (second and third trimesters)
- Severe renal impairment (creatinine clearance <30 mL/min) or anuria
- Severe hepatic impairment
- Concomitant use with aliskiren in patients with diabetes mellitus or renal impairment (GFR <60 mL/min/1.73 m²)
- Hypersensitivity to ramipril, hydrochlorothiazide, sulfonamide-derived medicines, or any excipients
Drug Interactions
NSAIDs
Reduced antihypertensive effect and increased risk of renal impairment.
Alcohol
Potentiation of orthostatic hypotension.
Lithium
Increased serum lithium concentrations and toxicity.
Aliskiren
Increased risk of hypotension, hyperkalemia, and renal impairment in diabetic patients or those with renal impairment.
Diuretics (other)
Potentiation of antihypertensive effect.
Antidiabetic agents
Increased risk of hypoglycemia.
Potassium-sparing diuretics/Potassium supplements
Increased risk of hyperkalemia.
Storage
Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children.
Overdose
Symptoms of overdose include severe hypotension, bradycardia, electrolyte disturbances (e.g., hypokalemia, hyponatremia), and dehydration. Management involves symptomatic and supportive treatment, including intravenous fluid administration and correction of electrolyte imbalances. Hemodialysis is not effective for ramiprilat, but effective for hydrochlorothiazide.
Pregnancy & Lactation
Protace-H is contraindicated in the second and third trimesters of pregnancy due to risks to the fetus. It is not recommended during the first trimester. Hydrochlorothiazide is excreted in breast milk; ramipril may also be. Therefore, use is not recommended during breastfeeding.
Side Effects
Contraindications
- History of angioedema related to previous ACE inhibitor treatment
- Hereditary or idiopathic angioedema
- Pregnancy (second and third trimesters)
- Severe renal impairment (creatinine clearance <30 mL/min) or anuria
- Severe hepatic impairment
- Concomitant use with aliskiren in patients with diabetes mellitus or renal impairment (GFR <60 mL/min/1.73 m²)
- Hypersensitivity to ramipril, hydrochlorothiazide, sulfonamide-derived medicines, or any excipients
Drug Interactions
NSAIDs
Reduced antihypertensive effect and increased risk of renal impairment.
Alcohol
Potentiation of orthostatic hypotension.
Lithium
Increased serum lithium concentrations and toxicity.
Aliskiren
Increased risk of hypotension, hyperkalemia, and renal impairment in diabetic patients or those with renal impairment.
Diuretics (other)
Potentiation of antihypertensive effect.
Antidiabetic agents
Increased risk of hypoglycemia.
Potassium-sparing diuretics/Potassium supplements
Increased risk of hyperkalemia.
Storage
Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children.
Overdose
Symptoms of overdose include severe hypotension, bradycardia, electrolyte disturbances (e.g., hypokalemia, hyponatremia), and dehydration. Management involves symptomatic and supportive treatment, including intravenous fluid administration and correction of electrolyte imbalances. Hemodialysis is not effective for ramiprilat, but effective for hydrochlorothiazide.
Pregnancy & Lactation
Protace-H is contraindicated in the second and third trimesters of pregnancy due to risks to the fetus. It is not recommended during the first trimester. Hydrochlorothiazide is excreted in breast milk; ramipril may also be. Therefore, use is not recommended during breastfeeding.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 2-3 years from manufacturing date.
Availability
Available in pharmacies nationwide
Approval Status
Approved by regulatory authorities in Bangladesh and globally.
Patent Status
Generic available
WHO Essential Medicine
YesClinical Trials
Extensive clinical trials have demonstrated the efficacy and safety of ramipril/hydrochlorothiazide combinations in reducing blood pressure and cardiovascular events in hypertensive patients.
Lab Monitoring
- Serum electrolytes (potassium, sodium, chloride)
- Renal function (creatinine, BUN)
- Blood pressure
- Liver function tests
- Uric acid
- Blood glucose
Doctor Notes
- Emphasize regular monitoring of blood pressure, renal function, and serum electrolytes.
- Advise patients about potential for orthostatic hypotension, especially at initiation.
- Counsel on the importance of adherence and lifestyle modifications.
- Caution against use in pregnancy and breastfeeding.
Patient Guidelines
- Take the medicine at the same time each day, preferably in the morning.
- Do not stop taking the medicine abruptly without consulting your doctor.
- Avoid excessive alcohol consumption.
- Inform your doctor about all other medications you are taking.
- Report any swelling of the face, lips, tongue, or throat immediately.
Missed Dose Advice
If a dose is missed, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and resume your regular dosing schedule. Do not double the dose to catch up.
Driving Precautions
This medicine may cause dizziness or fatigue, especially at the start of treatment or when changing doses. Avoid driving or operating machinery until you know how it affects you.
Lifestyle Advice
- Adopt a healthy diet low in sodium and rich in fruits, vegetables, and whole grains.
- Engage in regular physical activity.
- Maintain a healthy weight.
- Limit alcohol intake.
- Quit smoking if applicable.
- Monitor blood pressure regularly at home.
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Global Brand Names
International brand names for this medicine. Click a brand to search for detailed information.