Nebistar-H (12.5/5 mg) Tablet

Manufactured byLupin Ltd.
ContainsHydrochlorothiazide (12.5 mg) + Nebivolol (5 mg)
Description

Nebistar-H (12.5/5 mg) Tablet is a combination medicine used for the treatment of high blood pressure. Frequent monitoring of blood pressure and electrolytes level is necessary during treatment with this medicine. Patients are advised to maintain a strict exercise and diet regimen along with this medicine for the best possible effect.

Substitutes

List of substitutes for Nebistar-H (12.5/5 mg) Tablet

Side effects

Major & minor side effects for Nebistar-H (12.5/5 mg) Tablet

  • Increased urination
  • Abdominal and stomach pain
  • Dry mouth
  • Joint pain, stiffness, and swelling
  • Cramping
  • Headache
  • Dizziness
  • Unusual tiredness and weakness
  • Diarrhea
  • Increase in body fat and cholesterol
  • Sleeplessness
  • Swelling of face, lips, eyelids, tongue, hands and feet
  • Chest pain and discomfort
  • Decreased blood pressure
  • Difficulty in breathing
  • Weight gain
  • Allergic Skin Reaction

Uses of Nebistar-H (12.5/5 mg) Tablet

What is it prescribed for?

  • Essential hypertension
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Concerns

Commonly asked questions

  • Onset of action
    The effect of this medicine can be observed within 1 hour of administration of the dose.
  • Duration of effect
    The effect of this medicine lasts for an average duration of 12 hours.
  • Safe with alcohol?
    Consumption of alcohol is not recommended during treatment with this medicine due to the increased risk of side effects such as dizziness, lightheadedness, and fainting. It is advised that you do not perform any activities that require high mental alertness such as driving a vehicle or operating machinery if you consume alcohol during treatment with this medicine.
  • Is it habit forming?
    No habit-forming tendencies were reported.
  • Usage in pregnancy?
    This medicine is not recommended for use in pregnant women except in life-threatening conditions. All the risks and benefits should be discussed with the doctor before taking this medicine. Your doctor may prescribe a safer alternative based on your clinical condition.
  • Usage while breast-feeding?
    This medicine is not recommended for use in breastfeeding women unless absolutely necessary. All the risks and benefits should be discussed with the doctor before taking this medicine. Your doctor may advise you to discontinue breastfeeding or to discontinue the drug based on your clinical condition.

Allergy

This medicine is not recommended for use in patients with a known allergy to hydrochlorothiazide, other sulfonamides, nebivolol, other beta-blockers, or any other inactive ingredients present along with these medicines.

Anuria

This medicine is not recommended for use in patients with anuria, a condition where the kidney is unable to produce urine.

Liver disease

This medicine is not recommended for use in patients with a severe liver impairment since the safety and efficacy of use are not clinically established.

Circulatory disorders

This medicine is not recommended for use in patients with circulatory disorders due to the increased risk of severe adverse effects.

Heart diseases

This medicine is not recommended for use in patients with heart diseases such as a heart block, sinus bradycardia, heart failure, cardiogenic shock, or sick sinus syndrome since it may worsen the patient's condition.

Respiratory diseases

This medicine is not recommended for use in patients with respiratory diseases such as bronchial asthma, bronchospasm, etc. since it may worsen the patient's condition.

Severe renal impairment

This medicine is not recommended for use in patients with severe renal impairment due to the increased risk of serious adverse effects.
Warnings for special population

Pregnancy

This medicine is not recommended for use in pregnant women except in life-threatening conditions. All the risks and benefits should be discussed with the doctor before taking this medicine. Your doctor may prescribe a safer alternative based on your clinical condition.

Breast-feeding

This medicine is not recommended for use in breastfeeding women unless absolutely necessary. All the risks and benefits should be discussed with the doctor before taking this medicine. Your doctor may advise you to discontinue breastfeeding or to discontinue the drug based on your clinical condition.
General warnings

Hepatic dysfunction

This medicine should be used with extreme caution in patients suffering from liver diseases due to an increase in the risk of serious adverse effects including coma. Close monitoring of liver function is advised while taking this medicine. Report any symptoms of confusion or jaundice to the doctor on priority. Replacement with a suitable alternative may be required in some cases based on the clinical condition.

Volume and electrolyte depletion

This medicine may alter the blood volume and electrolyte levels in some patients. This may cause dizziness, dry mouth, and acid-base imbalance. This risk is especially higher in patients suffering from kidney and liver diseases. Close monitoring of blood pressure and electrolyte levels is recommended for such patients. Appropriate dose adjustments or replacement with a suitable alternative may be required based on the clinical condition.

Renal diseases

This medicine may cause Azotemia in patients with a known history of severe renal diseases. Close monitoring of kidney function is necessary while taking this medicine. Replacement with a suitable alternative may be required based on the clinical condition.

Ischemic heart disease

This medicine is not recommended for use in patients with ischemic heart disease unless specified by the doctor. Since the risk of significant adverse effects is high in such patients on abrupt discontinuation of this medicine, your doctor will determine the appropriate course based on your clinical condition.

Major surgery

This medicine should be used with extreme caution in patients undergoing a major surgery due to the increased risk of severe adverse effects. Close monitoring of heart function is recommended for such patients. Discontinuation of therapy may be required based on the clinical condition.

Hyperthyroidism

This medicine should be administered with caution in patients suffering from hyperthyroidism since it may mask some of the patient's symptoms. Report any unusual symptoms to the doctor immediately. Close monitoring of thyroid hormone levels is recommended for such patient. Replacement with a suitable alternative may be required based on the clinical condition.

Peripheral vascular disease

This medicine should be used with caution in patients suffering from peripheral vascular diseases since it may worsen the patient's condition. Replacement with a suitable alternative may be required based on the clinical condition.

Use in pediatrics

This medicine is not recommended for use in patients below the age of 18 years since the safety and efficacy of use are not clinically established.

Missed Dose

Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose. Do not double your dose to make up for the missed one.

Overdose

Seek emergency medical treatment or contact the doctor in case of an overdose.
All drugs interact differently for person to person. You should check all the possible interactions with your doctor before starting any medicine.
Interaction with Alcohol

Description

N/A

Instructions

Consumption of alcohol is not recommended during treatment with this medicine due to the increased risk of side effects such as dizziness, lightheadedness, and fainting. It is advised that you do not perform any activities that require high mental alertness such as driving a vehicle or operating machinery if you consume alcohol during treatment with this medicine.
Interaction with Medicine

Amlodipine

Baclofen

Diltiazem

Fluoxetine

Amiodarone

Insulin

Aminophylline

Ergotamine

Antidepressants

Nonsteroidal anti-inflammatory medicines

Disease interactions

Hyperuricemia

This medicine should be used with caution in patients with a history of gout or chronic renal failure due to the increased risk of hyperuricemia. Close monitoring of uric acid level is recommended for such patients. Replacement with a suitable alternative may be necessary based on the clinical condition of the patient.

Asthma

This medicine is not recommended for use in patients with bronchial asthma or chronic obstructive pulmonary disease since it may worsen the patient's condition. Replacement with a suitable alternative should be done under your doctor's supervision.

Heart Block

This medicine is not recommended for use in patients with a greater than first-degree heart block unless a permanent pacemaker is present.

Diabetes

This medicine should be administered with caution in patients with diabetes since it may alter blood glucose levels and mask the symptoms of low blood glucose levels. Close monitoring of blood glucose levels is recommended for such patients. Replacement with a suitable alternative or appropriate dose adjustments of antidiabetic agents may be required based on the clinical condition.

Liver Disease

This medicine should be used with caution in patients suffering from liver diseases due to the increased risk of severe adverse effects. Replacement with a suitable alternative may be required based on the clinical condition.

Glaucoma

This medicine should be administered with caution in patients suffering from glaucoma. A change in the dose of the current glaucoma medicine may be required in some cases. Replacement with a suitable alternative may be necessary based on the clinical condition.

High cholesterol levels

This medicine should be administered with caution in patients having high levels of cholesterol since it may worsen the patient's condition. Close monitoring of cholesterol levels is recommended for such patients. Replacement with a suitable alternative may be required based on the clinical condition.

Hyperthyroidism

This medicine should be used with caution in patients suffering from hyperthyroidism since it may mask the symptoms of such patient. Close monitoring of thyroid hormone levels is recommended for such patients. Replacement with a suitable alternative may be required based on the clinical condition.

Myasthenia Gravis

This medicine should be used with caution in patients suffering from myasthenia gravis since it may worsen the patient's condition. Report any unusual symptoms to the doctor immediately. Replacement with a suitable alternative may be necessary based on the clinical condition.

Pheochromocytoma

This medicine should be used with extreme caution in patients with pheochromocytoma since it may worsen the patient's condition. Close monitoring of blood pressure and vital signs is recommended for such patients. Replacement with a suitable alternative may be necessary based on the clinical condition.
Food interactions
Information not available.
Lab interactions
Information not available.
Take this medicine exactly as advised by your doctor. Do not take in larger amounts than prescribed. It is advised to take this medicine at daytime to prevent sleep disturbance. Drink an adequate amount of water. Monitoring of kidney function and electrolytes levels is necessary while taking this medicine. Report any adverse effects to the doctor on priority. Do not stop the use of this medicine without consulting your doctor.
Miscelleneous

Can be taken with or without food, as advised by your doctor

To be taken as instructed by doctor

May cause sleepiness

How it works
Hydrochlorothiazide increases the excretion of water and sodium through the urine. Nebivolol relaxes the blood vessels and reduces the heart rate, promoting a smooth flow of the blood. Their combination is thus effective in reducing the blood pressure.
Legal Status

Approved

Unknown

Approved

Unknown

Classification

Category

Antihypertensive combinations, Cardioselective beta blockers with thiazides

Schedule

Schedule H

[Internet]. 2017 [cited 29 September 2017]. Available from:

http://www.mhra.gov.uk/home/groups/spcpil/documents/spcpil/con1503034072090.pdf

Nebivolol - DrugBank [Internet]. Drugbank.ca. 2017 [cited 29 September 2017]. Available from:

https://www.drugbank.ca/drugs/DB04861

[Internet]. Whocc.no. 2017 [cited 29 September 2017]. Available from:

https://www.whocc.no/atc_ddd_index/?code=C07BB12

Efficacy of Initial Combo Therapy with Hctz | Bystolic® (nebivolol) [Internet]. Bystolichcp.com. 2017 [cited 29 September 2017]. Available from:

http://www.bystolichcp.com/efficacy/initial-combination-therapy-with-hydrochlorothiazide
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