Co-vasotec® — Valsartan / Hydrochlorothiazide — Film-Coated Tablets
1- Disclaimer
This information is intended for healthcare-professional and educational reference and does not replace the current locally approved prescribing information, the physician's clinical judgment, or individualized medical advice. Product registration details, formulations, warnings, and recommendations may change over time; the currently approved Egyptian product information should take precedence.
We do not guarantee the accuracy, currency or completeness of information regarding medications or medical products, and official sources should be verified before making any decisions. Readers are responsible for independently verifying the information before relying on it.
Co-vasotec is a prescription antihypertensive medicine. Treatment initiation, dose adjustment, discontinuation, and monitoring should be performed by a qualified healthcare professional.
2- Summary
Co-vasotec is a fixed-dose antihypertensive combination containing valsartan, an angiotensin II receptor blocker (ARB), and hydrochlorothiazide, a thiazide diuretic. The two components lower blood pressure through complementary mechanisms: valsartan reduces angiotensin-II-mediated vasoconstriction and aldosterone effects, while hydrochlorothiazide increases renal sodium and chloride excretion and reduces plasma volume.
It is used for the treatment of hypertension in adults when combination therapy is appropriate, particularly where blood pressure is not adequately controlled with either component alone. Some prescribing frameworks also permit initial combination therapy in selected patients expected to require more than one antihypertensive agent; the current locally approved Egyptian prescribing information should determine the appropriate indication and starting regimen.
3- Brand Name
Co-vasotec®
The Egyptian product information identifies the product as Co-vasotec and EIPICO as the associated pharmaceutical company.
4- Category
- Antihypertensive.
- Fixed-dose combination of:
- Angiotensin II receptor blocker (ARB): valsartan
- Thiazide diuretic: hydrochlorothiazide
- Pharmacotherapeutic group: angiotensin II antagonists combined with diuretics.
- ATC classification for valsartan/hydrochlorothiazide: C09DA03.
5- Active Ingredient
Each film-coated tablet contains one of the following combinations:
- Valsartan 80 mg + Hydrochlorothiazide 12.5 mg
- Valsartan 160 mg + Hydrochlorothiazide 12.5 mg
- Valsartan 160 mg + Hydrochlorothiazide 25 mg
These are the three strengths identified for Co-vasotec in the Egyptian product material.
6- Pharmaceutical Form & Strength
Pharmaceutical form: Film-coated tablets.
Available strengths documented for Co-vasotec:
- Co-vasotec 80/12.5 mg
- Co-vasotec 160/12.5 mg
- Co-vasotec 160/25 mg
The Egyptian leaflet describes each pack as containing 14 film-coated tablets, supplied as two blisters of seven tablets.
7- Manufacturer & Marketing Authorization Holder
Manufacturer / company identified on the product:
Egyptian International Pharmaceutical Industries Co. (EIPICO)
Tenth of Ramadan City, Egypt.
EIPICO's official product information identifies Co-vasotec as an EIPICO cardiovascular product and confirms valsartan/hydrochlorothiazide as its active combination.
A separate marketing-authorization-holder entity is not clearly identified in the publicly available product material reviewed; the current Egyptian pack and official Egyptian registration record should therefore be consulted if the exact current MAH is required.
8- Mechanism of Action
Valsartan
Valsartan is a selective antagonist of the angiotensin II AT1 receptor. Angiotensin II normally causes vasoconstriction, stimulates aldosterone secretion, and promotes sodium retention. By blocking AT1 receptors, valsartan reduces these actions and consequently lowers blood pressure.
Valsartan does not inhibit angiotensin-converting enzyme (ACE) and therefore does not directly inhibit bradykinin degradation.
Hydrochlorothiazide
Hydrochlorothiazide acts mainly in the distal convoluted tubule, where it inhibits the sodium/chloride cotransporter. This increases urinary sodium and chloride excretion, followed by water loss, reducing circulating plasma volume and blood pressure. It may also increase potassium and magnesium loss.
Combination Effect
The components have complementary antihypertensive actions. Valsartan can also partly counterbalance the potassium-lowering effect produced by hydrochlorothiazide, although clinically important hypo- or hyperkalaemia can still occur and serum electrolytes require monitoring.
9- Spectrum of Activity
Not applicable in the antimicrobial sense.
Co-vasotec is not an antibacterial, antiviral, antifungal, or antiparasitic medicine. Its pharmacological activity is directed toward the cardiovascular and renal systems through blockade of angiotensin II AT1 receptors and thiazide-induced natriuresis.
10- Pharmacokinetics
Valsartan
Following oral administration, peak plasma concentrations are generally reached within approximately 2–4 hours. Mean absolute bioavailability is approximately 23%.
Valsartan is highly protein bound, approximately 94–97%, mainly to albumin. It undergoes limited metabolism and is eliminated predominantly in feces, with a smaller proportion excreted in urine, mainly as unchanged drug. Its terminal elimination half-life is approximately 6 hours in current reference product information.
Food decreases measured valsartan exposure, but this reduction has not been associated with a clinically significant reduction in antihypertensive efficacy; valsartan/hydrochlorothiazide may therefore generally be taken with or without food.
Hydrochlorothiazide
Hydrochlorothiazide is rapidly absorbed, with peak concentrations occurring at approximately 2 hours. Absolute bioavailability is about 70% in current reference information.
Its terminal plasma half-life averages approximately 6–15 hours, and more than 95% of the absorbed dose is eliminated unchanged in the urine.
When hydrochlorothiazide is co-administered with valsartan, its systemic availability is reduced by approximately 30%; this interaction has not been shown to reduce the clinical usefulness of the combination.
11- Indications
Co-vasotec is used for the treatment of hypertension in adults.
Fixed-dose valsartan/hydrochlorothiazide is particularly appropriate when blood pressure is not adequately controlled by valsartan or hydrochlorothiazide alone.
The Egyptian product information also describes use of the combination in selected patients in whom more than one antihypertensive agent is likely to be necessary to achieve the required blood-pressure target.
Treatment decisions and blood-pressure targets should be individualized according to the patient's cardiovascular risk, comorbidities, renal function, electrolyte status, and current hypertension guidelines.
12- Administration
Co-vasotec is administered orally once daily.
The Egyptian product information describes 80/12.5 mg once daily as the usual starting strength, with escalation to 160/12.5 mg when response remains inadequate and use of 160/25 mg where adequate blood-pressure reduction is not achieved with 160/12.5 mg. Dose changes should be made by the treating physician.
For valsartan/hydrochlorothiazide combinations, substantial antihypertensive activity is generally present within approximately 2 weeks, with maximal effect commonly developing within about 4 weeks, although some patients may require longer.
The tablet can generally be taken with or without food and should be swallowed with water.
Do not increase the dose or combine different strengths without medical supervision.
13- Method of Preparation
No preparation or reconstitution is required.
Co-vasotec is supplied as a ready-to-administer film-coated tablet. It should be taken orally as prescribed.
14- Contraindications
Important contraindications for valsartan/hydrochlorothiazide include:
- Hypersensitivity to valsartan, hydrochlorothiazide, product excipients, or other sulfonamide-derived medicines according to relevant product labeling.
- Anuria.
- Severe renal impairment, generally defined in European product information as GFR/creatinine clearance below approximately 30 mL/min.
- Severe hepatic impairment, biliary cirrhosis, or cholestasis.
- Refractory hypokalaemia, hyponatraemia, hypercalcaemia, or symptomatic hyperuricaemia in product information using these contraindications.
- Concomitant treatment with aliskiren in patients with diabetes mellitus or renal impairment (GFR <60 mL/min/1.73 m²) according to European product information.
- Pregnancy: the Egyptian Co-vasotec product information lists pregnancy as contraindicated. European valsartan/hydrochlorothiazide prescribing information specifies that use of angiotensin II receptor antagonists is not recommended during the first trimester and is contraindicated during the second and third trimesters. Treatment should be discontinued promptly when pregnancy is recognized.
15- Warnings & Precautions
Fetal toxicity
Medicines acting on the renin-angiotensin system can cause serious fetal injury. Exposure later in pregnancy can cause reduced fetal renal function, oligohydramnios, pulmonary and skeletal complications, neonatal hypotension, renal failure, and death. Stop valsartan-containing treatment promptly when pregnancy is detected and arrange appropriate alternative therapy.
Hypotension and volume depletion
Symptomatic hypotension can occur, particularly in patients who are sodium- or volume-depleted, including those receiving high-dose diuretics. Volume or sodium depletion should generally be corrected before treatment.
Renal impairment
Valsartan and diuretics may impair renal function in susceptible patients, particularly those with chronic kidney disease, renal artery stenosis, severe heart failure, or volume depletion. Renal function should be monitored.
Electrolyte disturbances
Hydrochlorothiazide can cause hypokalaemia, hyponatraemia and hypomagnesaemia and may increase serum calcium. Valsartan may cause hyperkalaemia. Periodic monitoring of electrolytes is therefore appropriate.
Metabolic effects
Hydrochlorothiazide may increase serum uric acid and precipitate gout, alter glucose tolerance, and increase cholesterol and triglyceride concentrations in some patients.
Angioedema
Angioedema has been reported with valsartan. Treatment should be stopped immediately if clinically significant angioedema develops; airway involvement is a medical emergency. Intestinal angioedema has also been reported with angiotensin II receptor antagonists.
Acute ocular reactions
Hydrochlorothiazide can rarely cause choroidal effusion, acute transient myopia, and secondary acute angle-closure glaucoma. Sudden eye pain or sudden reduction in vision requires urgent medical assessment.
Photosensitivity and non-melanoma skin cancer
Long-term cumulative hydrochlorothiazide exposure has been associated in observational studies with an increased risk of non-melanoma skin cancer, particularly basal-cell and squamous-cell carcinoma. Patients should limit excessive ultraviolet exposure, use appropriate sun protection, and report suspicious or changing skin lesions.
Acute respiratory toxicity
Very rare severe acute respiratory reactions, including acute respiratory distress syndrome (ARDS) and pulmonary oedema, have been reported after hydrochlorothiazide. Sudden severe dyspnoea, fever, hypotension, or rapidly worsening respiratory symptoms following treatment require immediate medical evaluation. Hydrochlorothiazide should not be re-administered to a patient who previously developed HCTZ-associated ARDS.
Systemic lupus erythematosus
Thiazide diuretics may exacerbate or activate systemic lupus erythematosus.
16- Drug Interactions
Clinically important interactions include:
- Lithium: valsartan and hydrochlorothiazide may increase serum lithium concentrations and lithium toxicity. Concomitant use is generally discouraged unless lithium can be carefully monitored.
- Potassium supplements, potassium-containing salt substitutes, potassium-sparing diuretics, heparin and other potassium-raising drugs: increased risk of hyperkalaemia due to valsartan.
- ACE inhibitors, other ARBs and aliskiren: dual RAAS blockade increases the risk of hypotension, hyperkalaemia, and renal dysfunction and is generally not recommended.
- NSAIDs including COX-2 inhibitors: may reduce antihypertensive and diuretic efficacy and increase the risk of deterioration in renal function, particularly in elderly, dehydrated, or renally impaired patients.
- Insulin and oral antidiabetic medicines: dosage adjustment may occasionally be necessary because hydrochlorothiazide may affect glucose tolerance.
- Digoxin and other cardiac glycosides: hydrochlorothiazide-induced hypokalaemia or hypomagnesaemia can increase susceptibility to cardiac glycoside toxicity.
- Carbamazepine: may increase the risk of symptomatic hyponatraemia.
- Cholestyramine and colestipol: can reduce hydrochlorothiazide absorption; dosing separation may be required.
- Ciclosporin: may increase the risk of hyperuricaemia and gout.
- Alcohol, barbiturates, narcotics and other antihypertensives: may enhance hypotension or orthostatic hypotension.
- Non-depolarizing skeletal-muscle relaxants: thiazides may increase responsiveness to these agents.
17- Side Effects
Adverse reactions reported with valsartan/hydrochlorothiazide include:
Adverse reactions reported with the valsartan/hydrochlorothiazide combination
Uncommon:
- Dehydration
- Paraesthesia
- Blurred vision
- Tinnitus
- Hypotension
- Cough
- Myalgia
- Fatigue
Very rare:
- Dizziness
- Diarrhoea
- Arthralgia
Frequency not known:
- Syncope
- Non-cardiogenic pulmonary oedema
- Impaired renal function
- Increased serum uric acid
- Increased serum bilirubin
- Increased serum creatinine
- Hypokalaemia
- Hyponatraemia
- Increased blood urea nitrogen
- Neutropenia
Additional adverse reactions associated with the individual components
Adverse reactions known to occur with valsartan or hydrochlorothiazide individually may also occur during treatment with the combination even if they were not observed in combination clinical trials.
Hydrochlorothiazide-related reactions include:
Very common: hypokalaemia and increased blood lipids, particularly at higher doses.
Common: hyponatraemia, hypomagnesaemia, hyperuricaemia, postural hypotension, loss of appetite, mild nausea and vomiting, urticaria or other forms of rash, and impotence.
Rare: thrombocytopenia, hypercalcaemia, hyperglycaemia, glycosuria or worsening diabetic metabolic control, depression, sleep disturbances, headache, dizziness, paraesthesia, visual impairment, cardiac arrhythmias, constipation, gastrointestinal discomfort, diarrhoea, intrahepatic cholestasis or jaundice, and photosensitivity.
Very rare: agranulocytosis, leukopenia, haemolytic anaemia, bone-marrow failure, hypersensitivity reactions, hypochloraemic alkalosis, acute respiratory distress syndrome (ARDS), respiratory distress including pneumonitis or pulmonary oedema, pancreatitis, necrotising vasculitis, toxic epidermal necrolysis, and cutaneous lupus erythematosus-like reactions or reactivation.
Frequency not known: non-melanoma skin cancer, aplastic anaemia, choroidal effusion, acute angle-closure glaucoma, renal dysfunction or acute renal failure, erythema multiforme, pyrexia, asthenia, and muscle spasm.
Valsartan and postmarketing valsartan/valsartan-hydrochlorothiazide reports additionally include: angioedema, hypersensitivity reactions, thrombocytopenia, increased serum potassium, hyponatraemia, vasculitis, abdominal pain, intestinal angioedema, elevated liver-function values or hepatitis, bullous dermatitis, rash, pruritus, renal failure or impairment, rhabdomyolysis, alopecia, and syncope. For many postmarketing reactions, frequency cannot be reliably estimated.
18- Use in Special Populations
Pregnancy
The Egyptian Co-vasotec product information lists pregnancy as contraindicated. In European valsartan/hydrochlorothiazide prescribing information, the use of angiotensin II receptor antagonists is not recommended during the first trimester of pregnancy and is contraindicated during the second and third trimesters. Valsartan-containing treatment should be discontinued promptly once pregnancy is recognized and an appropriate alternative antihypertensive treatment should be considered.
Breastfeeding
Hydrochlorothiazide is excreted in human milk, while adequate clinical information regarding valsartan during breastfeeding is lacking. Breastfeeding during valsartan/hydrochlorothiazide treatment is not recommended; an antihypertensive with a better-established lactation safety profile is generally preferred, especially for newborn or premature infants.
Children and adolescents
Valsartan/hydrochlorothiazide fixed-dose combinations are not recommended in patients below 18 years of age because adequate safety and efficacy data are lacking.
Older adults
Age alone does not generally require dose adjustment, but renal function, hydration status, electrolytes, blood pressure, and concomitant therapy should be considered.
Renal impairment
No dose adjustment is generally required for mild-to-moderate impairment where GFR is at least approximately 30 mL/min, although renal function and electrolytes require monitoring. Severe renal impairment and anuria are contraindications in relevant product information.
Hepatic impairment
In patients with mild-to-moderate hepatic impairment without cholestasis, European reference information recommends that the valsartan dose should not exceed 80 mg. Therefore, fixed-dose strengths containing 160 mg of valsartan would exceed this recommended valsartan dose limit in such patients. The combination should be used with caution, and severe hepatic impairment, biliary cirrhosis, and cholestasis are contraindications.
19- Storage Conditions
Store at a temperature not exceeding 30°C and protect from moisture.
Keep in the original package where applicable and keep all medicines out of the reach of children.
Do not use after the expiry date printed on the package. The Egyptian Co-vasotec leaflet likewise specifies storage below 30°C in a dry place.
20- Additional Sections
Monitoring
Clinical monitoring may include:
- Blood pressure
- Serum potassium and sodium
- Renal function/serum creatinine
- Uric acid where clinically relevant
- Glucose in patients with diabetes or impaired glucose tolerance
- Symptoms of dehydration or hypotension
- New or changing skin lesions during prolonged hydrochlorothiazide exposure
Ability to Drive and Operate Machinery
Dizziness, hypotension, or fatigue may occasionally occur. Patients should determine how treatment affects them before driving or operating machinery.
Overdose
Valsartan overdose may cause pronounced hypotension and potentially circulatory collapse. Hydrochlorothiazide overdose may produce nausea, somnolence, hypovolaemia and clinically significant electrolyte disturbances, potentially leading to arrhythmias or muscle cramps.
Treatment is supportive, with priority given to restoration of blood pressure, fluid volume, and electrolyte balance. Because valsartan is strongly protein-bound, it is not expected to be effectively removed by haemodialysis; hydrochlorothiazide can be removed to some extent by dialysis.
21- Frequently Asked Questions (FAQ)
Q1: What is Co-vasotec used for?
It is used to lower elevated blood pressure in adults using the complementary effects of valsartan and hydrochlorothiazide.
Q2: Can Co-vasotec be taken with food?
Yes. Valsartan/hydrochlorothiazide combinations may generally be taken with or without food and should be swallowed with water.
Q3: How quickly does it lower blood pressure?
A substantial antihypertensive effect is usually present within about two weeks. Maximum effect is commonly reached within approximately four weeks, although some patients may require longer.
Q4: Can children use Co-vasotec?
Routine use of the fixed valsartan/hydrochlorothiazide combination is not recommended below 18 years because adequate safety and efficacy data are unavailable.
Q5: Can it be used during pregnancy?
The Egyptian Co-vasotec information lists pregnancy as contraindicated. European valsartan/hydrochlorothiazide prescribing information states that ARB therapy is not recommended during the first trimester and is contraindicated during the second and third trimesters. If pregnancy occurs, valsartan-containing treatment should be stopped promptly and the treating physician should select an appropriate alternative.
Q6: Can potassium supplements be taken with Co-vasotec?
Only when specifically recommended by a healthcare professional. Valsartan can raise serum potassium, and potassium supplements, potassium-containing salt substitutes, and potassium-sparing medicines may further increase this risk.
Q7: What laboratory monitoring may be required?
Renal function and serum electrolytes—particularly potassium and sodium—should be assessed when clinically appropriate, especially in patients with kidney disease, volume depletion, diabetes, or interacting medicines.
Q8: Is sun protection important with hydrochlorothiazide?
Yes. Hydrochlorothiazide can cause photosensitivity and cumulative exposure has been associated with an increased risk of non-melanoma skin cancer. Patients should avoid excessive UV exposure, use adequate sun protection, and report suspicious skin lesions.
22- References
- Co-vasotec Egyptian product leaflet / EIPICO product information — identifies the brand, active ingredients, strengths, administration, contraindications, storage conditions and manufacturer/company information.
- EIPICO official product information — Co-vasotec listed as an EIPICO cardiovascular valsartan/hydrochlorothiazide product.
- DailyMed – DIOVAN HCT (valsartan/hydrochlorothiazide), Novartis Pharmaceuticals Corporation — prescribing information for valsartan/hydrochlorothiazide.
- DailyMed – Valsartan and Hydrochlorothiazide Tablets — prescribing information for generic valsartan/hydrochlorothiazide products.
- Co-Diovan 80/12.5 mg, 160/12.5 mg and 160/25 mg – Summary of Product Characteristics, electronic Medicines Compendium — reference product information for dosing, contraindications, pharmacokinetics, interactions, pregnancy, adverse reactions, and hydrochlorothiazide safety warnings.
- National/local prescribing information should always be consulted because indications, contraindications, available strengths, and regulatory wording can differ between countries and products.