What is Provanol?
Provanol is used alone or together with other medicines to treat high blood pressure (hypertension). High blood pressure adds to the workload of the heart and arteries. If it continues for a long time, the heart and arteries may not function properly. This can damage the blood vessels of the brain, heart, and kidneys, resulting in a stroke, heart failure, or kidney failure. Lowering blood pressure may reduce the risk of stroke and heart attacks.
Provanol is also used to treat severe chest pain (angina), migraine headaches, or hypertrophic subaortic stenosis (thickened heart muscle).
Provanol may also be used to treat irregular heartbeats, tremors, or pheochromocytoma (adrenal gland tumor). It may also be used to reduce the risk of death in patients who have heart attacks.
Provanol oral solution is used to treat proliferating infantile hemangioma.
Provanol is a beta-blocker. It works by affecting the response to nerve impulses in certain parts of the body, like the heart. As a result, the heart beats slower and decreases the blood pressure. When the blood pressure is lowered, the amount of blood and oxygen is increased to the heart.
Provanol is available only with your doctor's prescription.
Provanol indications
Hypertension
Provanol is indicated in the management of hypertension. It may be used alone or used in combination with other antihypertensive agents, particularly a thiazide diuretic. Provanol is not indicated in the management of hypertensive emergencies.
Angina Pectoris Due to Coronary Atherosclerosis
Provanol is indicated to decrease angina frequency and increase exercise tolerance in patients with angina pectoris.
Atrial Fibrillation
Provanol is indicated to control ventricular rate in patients with atrial fibrillation and a rapid ventricular response.
Myocardial Infarction
Provanol is indicated to reduce cardiovascular mortality in patients who have survived the acute phase of myocardial infarction and are clinically stable.
Migraine
Provanol is indicated for the prophylaxis of common migraine headache. The efficacy of Provanol in the treatment of a migraine attack that has started has not been established, and Provanol is not indicated for such use.
Essential Tremor
Provanol is indicated in the management of familial or hereditary essential tremor. Familial or essential tremor consists of involuntary, rhythmic, oscillatory movements, usually limited to the upper limbs. It is absent at rest, but occurs when the limb is held in a fixed posture or position against gravity and during active movement. Provanol causes a reduction in the tremor amplitude, but not in the tremor frequency. Provanol is not indicated for the treatment of tremor associated with Parkinsonism.
Hypertrophic Subaortic Stenosis
Provanol improves NYHA functional class in symptomatic patients with hypertrophic subaortic stenosis.
Pheochromocytoma
Provanol is indicated as an adjunct to alpha-adrenergic blockade to control blood pressure and reduce symptoms of catecholamine-secreting tumors.
How should I use Provanol?
Use Provanol solution as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Provanol solution comes with extra patient information sheets called a Medication Guide and Instructions for Use. Read them carefully. Read them again each time you get Provanol solution refilled.
- Do NOT shake Provanol solution before use.
- Use the syringe that comes with Provanol solution to measure the dose. Ask the pharmacist for help if you are unsure of how to measure the dose.
- Give Provanol solution right into your child's mouth. If needed, Provanol solution may be mixed in a small amount of milk or fruit juice and given in a baby's bottle.
- Give Provanol solution with or right after a feeding.
- Give doses of Provanol solution at least 9 hours apart.
- The dose of Provanol solution may need to be changed as your child's weight changes. Have your child's weight checked often. Talk with the doctor before changing your child's dose.
- Give Provanol solution on a regular schedule to get the most benefit from it. Giving Provanol solution at the same time each day will help you remember to give it.
- If your child spits up a dose or if you are not sure your child got all of the medicine, do not give another dose. Wait until the next scheduled dose.
- If you miss giving your child a dose of Provanol solution, give it as soon as possible. If it is almost time for the next dose, skip giving the missed dose and go back to your child's regular dosing schedule. Do not give 2 doses at once.
Ask your health care provider any questions you may have about how to use Provanol solution.
Uses of Provanol in details
Use: Labeled Indications
Angina, chronic stable: To decrease angina frequency and increase exercise tolerance in patients with angina pectoris.
Cardiac arrhythmias: Control of supraventricular arrhythmias (eg, atrial fibrillation and flutter, atrioventricular nodal reentrant tachycardia) and ventricular tachycardias (eg, catecholamine-induced arrhythmias, digoxin toxicity).
Essential tremor: Management of familial or hereditary essential tremor.
Hypertension: Management of hypertension. Note: Beta-blockers are not recommended as first-line therapy (ACC/AHA [Whelton 2018]).
Migraine headache prophylaxis: Prophylaxis of common migraine headache.
Myocardial infarction, early treatment and secondary prevention: To reduce cardiovascular mortality in patients who have survived the acute phase of myocardial infarction and are clinically stable.
Obstructive hypertrophic cardiomyopathy: Symptomatic treatment of obstructive hypertrophic cardiomyopathy (formerly known as hypertrophic subaortic stenosis).
Pheochromocytoma: As an adjunct to alpha-adrenergic blockade to control blood pressure and reduce symptoms of catecholamine-secreting tumors.
Proliferating infantile hemangioma (Provanol): Treatment of proliferating infantile hemangioma requiring systemic therapy.
Off Label Uses
Akathisia, antipsychotic-induced
Data from a limited number of patients in 5 randomized, double-blind, controlled studies support the use of Provanol in antipsychotic-induced akathisia.
Based on the American Association for the Study of Liver Diseases guidelines on the management of portal hypertensive bleeding in cirrhosis and the British Society of Gastroenterology guidelines on the management of variceal hemorrhage in cirrhotic patients, use of nonselective beta-blockers, such as Provanol, is effective and recommended for primary and secondary prophylaxis of variceal hemorrhage.
Provanol description
A widely used non-cardioselective beta-adrenergic antagonist. R,S-Provanol is used in the treatment or prevention of many disorders including acute myocardial infarction, arrhythmias, angina pectoris, hypertension, hypertensive emergencies, hyperthyroidism, migraine, pheochromocytoma, menopause, and anxiety.
Provanol dosage
Provanol Dosage
Generic name: Provanol 80mg
Dosage form: capsule, extended release
See also:
- Provanol Tablets
- Provanol capsule, extended release
The information at Drugs.com is not a substitute for medical advice. Always consult your doctor or pharmacist.
Provanol should be administered once daily at bedtime and should be taken consistently either on an empty stomach or with food. Initiate dosing at 80 mg and titrate to 120 mg daily as needed for blood pressure control. Doses above 120 mg have no additional effects on blood pressure. The time needed for full antihypertensive response is variable, but is usually achieved within 2 to 3 weeks.
More about Provanol (Provanol)
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Consumer resources
- Provanol
- Provanol (Advanced Reading)
- Other brands: Provanol, Provanol, InnoPran XL, Provanol
Professional resources
- Provanol (FDA)
- Provanol (AHFS Monograph)
Related treatment guides
- Atrial Fibrillation
- Ventricular Tachycardia
Provanol interactions
See also:
What other drugs will affect Provanol?
Patients receiving catecholamine-depleting drugs such as reserpine should be closely observed if Provanol HCl is administered. The added catecholamine-blocking action may produce an excessive reduction of resting sympathetic nervous activity, which may result in hypotension, marked bradycardia, vertigo, syncopal attacks, or orthostatic hypotension.
Caution should be exercised when patients receiving a beta blocker are administered a calcium-channel blocking drug, especially intravenous verapamil, for both agents may depress myocardial contractility or atrioventricular conduction. On rare occasions, the concomitant intravenous use of a beta blocker and verapamil has resulted in serious adverse reactions, especially in patients with severe cardiomyopathy, congestive heart failure, or recent myocardial infarction.
Blunting of the antihypertensive effect of beta-adrenoceptor blocking agents by nonsteroidal anti-inflammatory drugs has been reported.
Hypotension and cardiac arrest have been reported with the concomitant use of Provanol and haloperidol.
Aluminum hydroxide gel: Greatly reduces intestinal absorption of Provanol.
Ethanol: Slows the rate of absorption of Provanol.
Phenytoin, phenobarbitone: and rifampin accelerate Provanol clearance.
Chlorpromazine: When used concomitantly with Provanol, results in increased plasma levels of both drugs.
Antipyrine: and lidocaine have reduced clearance when used concomitantly with Provanol.
Thyroxine: May result in a lower than expected T3 concentration when used concomitantly with Provanol.
Cimetidine Decreases the hepatic metabolism of Provanol, delaying elimination and incre:asing blood levels.
Theophylline: Clearance is reduced when used concomitantly with Provanol.
Provanol side effects
See also:
What are the possible side effects of Provanol?
The following serious adverse reactions are discussed in greater detail in other sections of the labeling:
- Hypoglycemia and related events, like hypoglycemic seizure.
- Bronchospasm.
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug may not reflect the rates observed in clinical practice.
Clinical Trials Experience with Provanol in Infants with proliferating infantile hemangioma
In clinical trials for proliferating infantile hemangioma, the most frequently reported adverse reactions ( > 10%) in infants treated with Provanol were sleep disorders, aggravated respiratory tract infections such as bronchitis and bronchiolitis associated with cough and fever, diarrhea, and vomiting. Adverse reactions led to treatment discontinuation in fewer than 2% of treated patients.
Overall, 479 patients in the pooled safety population were exposed to study drug in the clinical study program (456 in placebo-controlled trials). A total of 424 patients were treated with Provanol at doses 1.2 mg/kg/day or 3.4 mg/kg/day for 3 or 6 months. Of these, 63% of patients were aged 91-150 days and 37% were aged 35-90 days at randomization.
The following table lists according to the dosage the most common adverse reactions (treatment-emergent adverse events with an incidence at least 3% greater on one of the two doses than on placebo).
Table 2: Treatment-emergent adverse events occurring at least 3% more often on Provanol than on placebo.
| Reaction | Placebo N=236 | Provanol 1.2 mg/kg/day N=200 | Provanol 3.4 mg/kg/day N=224 |
| Sleep disorder | 5.90% | 17.50% | 16.10% |
| Bronchitis | 4.7 | 8 | 13.4 |
| Peripheral coldness | 0.4 | 8 | 6.7 |
| Agitation | 2.1 | 8.5 | 4.5 |
| Diarrhea | 1.3 | 4.5 | 6.3 |
| Somnolence | 0.4 | 5 | 0.9 |
| Nightmare | 1.7 | 2 | 6.3 |
| Irritability | 1.3 | 5.5 | 1.3 |
| Decreased appetite | 0.4 | 2.5 | 3.6 |
| Abdominal pain | 0.4 | 3.5 | 0.4 |
The following adverse events have been observed during clinical studies, with an incidence of less than 1%:
Cardiac disorders: Second degree atrioventricular heart block, in a patient with underlying conduction disorder, required definitive treatment discontinuation.
Skin and subcutaneous tissue disorders: Urticaria, alopecia
Investigations: Decreased blood glucose, decreased heart rate
Compassionate Use Program
More than 600 infants received Provanol in a compassionate use program (CUP). Mean age at treatment initiation was 3.6 months. Mean dose of Provanol was 2.2 mg/kg/day and mean treatment duration was 7.1 months.
The adverse reactions reported in the CUP were similar to the ADRs observed during clinical trials but some were more severe.
Postmarketing Experience
The following adverse reactions have been identified during post-approval use of Provanol. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
These adverse reactions are as follows:
Blood and lymphatic system disorders: Agranulocytosis
Psychiatric disorders: Hallucination
Skin and subcutaneous tissues disorders: Purpura
Provanol contraindications
See also:
What is the most important information I should know about Provanol?
You should not use this medication if you are allergic to Provanol, if you have asthma, a slow heart rate, or a serious heart condition such as "sick sinus syndrome" or "AV block" (unless you have a pacemaker).
If you need surgery, tell the surgeon ahead of time that you are using Provanol. You may need to stop using the medicine for a short time.
Do not skip doses or stop using Provanol without first talking to your doctor. You may need to use less and less before you stop the medication completely.
Avoid drinking alcohol. It may increase your blood levels of Provanol.
Provanol is only part of a complete program of treatment for hypertension that may also include diet, exercise, and weight control. Follow your diet, medication, and exercise routines very closely if you are being treated for hypertension.
If you are being treated for high blood pressure, keep using this medication even if you feel well. High blood pressure often has no symptoms. You may need to use blood pressure medication for the rest of your life.
Active ingredient matches for Provanol:
Propranolol hydrochloride in India.
| Unit description / dosage (Manufacturer) | Price, USD |
| 40 mg x 10's | $ 0.43 |
| Provanol 40mg SR-TAB / 10 | $ 0.43 |
| PROVANOL 10 MG TABLET 1 strip / 10 tablets each (Intas Pharmaceuticals Ltd) | $ 0.14 |
| PROVANOL 20 MG TABLET 1 strip / 10 tablets each (Intas Pharmaceuticals Ltd) | $ 0.28 |
| PROVANOL 40 MG TABLET 1 strip / 10 tablets each (Intas Pharmaceuticals Ltd) | $ 0.35 |
| PROVANOL 40 MG TABLET SR 1 strip / 10 tablet srs each (Intas Pharmaceuticals Ltd) | $ 0.52 |
| PROVANOL SR tab 40 mg x 10's (Intas) | $ 0.43 |
| Provanol 40mg SR-TAB / 10 | $ 0.43 |
| Provanol 10mg Tablet (Intas Pharmaceuticals Ltd) | $ 0.01 |
| Provanol 20mg Tablet (Intas Pharmaceuticals Ltd) | $ 0.03 |
| Provanol 40mg Tablet (Intas Pharmaceuticals Ltd) | $ 0.03 |
| Provanol 40mg Tablet SR (Intas Pharmaceuticals Ltd) | $ 0.06 |
List of Provanol substitutes (brand and generic names): | |
| Prosanol (Taiwan) | |
| Prosanol 40 mg | |
| PROZOLAM | |
| PROZOLAM 0.25MG TABLET 1 strip / 10 tablets each (Zaneka Healthcare Pvt Ltd) | $ 0.24 |
| PSYCOOL (India) | |
| 40 mg x 100's (Solitaire (Psychotop)) | $ 9.40 |
| Psycool 40mg TAB / 100 (Solitaire (Psychotop)) | $ 9.40 |
| PSYCOOL tab 40 mg x 10's (Solitaire (Psychotop)) | $ 0.94 |
| Psycool 40mg TAB / 100 (Solitaire (Psychotop)) | $ 9.40 |
| Pu Le Xin (China) | |
| Pu Su Xin (China) | |
| Pur-Bloka (South Africa) | |
| Pylapron | |
| R,S-Propranolol Hydrochloride | |
| Ranoprin (Finland) | |
| Rapynogen | |
| Rebaten (Brazil) | |
| Rebaten LA (Brazil) | |
| Reducor | |
| Reducor Line | |
| RELAX BB | |
| RELAX BB TABLET 1 strip / 20 tablets each (Logos Pharma) | $ 0.78 |
| RELAX MB | |
| RELAX MB TABLET 1 strip / 20 tablets each (Logos Pharma) | $ 0.72 |
| Rexigen (South Africa) | |
| Ritemed Propranolol (Philippines) | |
| RiteMED Propranolol 10 mg x 100's | $ 4.43 |
| RiteMED Propranolol 40 mg x 100's | $ 7.60 |
| Ropnol | |
| Ropnol 40mg Tablet SR (Wander Ltd) | $ 0.05 |
| Ropranolol GPO (Thailand) | |
| Ruz- Propranolol® | |
| Ruz- propranololВ® | |
| Sagittol (Germany) | |
| Sanpronol (Brazil) | |
| Sawatal | |
| Sawatal LA (Japan) | |
| Servanolol (Thailand) | |
| Shinpral (Japan) | |
| SIGNOLOL | |
| SIGNOLOL 10 MG TABLET 1 strip / 10 tablets each (Sigmund Promedica) | $ 0.14 |
| SIGNOLOL 20 MG TABLET 1 strip / 10 tablets each (Sigmund Promedica) | $ 0.19 |
| SIGNOLOL TR 40 MG TABLET 1 strip / 10 tablets each (Sigmund Promedica) | $ 0.32 |
| Signolol 10mg Tablet (Sigmund Promedica) | $ 0.01 |
| Signolol 20mg Tablet (Sigmund Promedica) | $ 0.02 |
| Signolol 40mg Tablet TR (Sigmund Promedica) | $ 0.03 |
| Sinlihaul (Taiwan) | |
| Sinlihaul 40 mg | |
| Sinlihaul 40 mg x Blister pk | |
| Sintaser (Mexico) | |
| Siron Plus (India) | |
| Siron Plus Propranolol hydrochloride 20mg, Alprazolam 0.25 mg. TAB / 10 (Gujarat Terce) | $ 0.17 |
See 1297 substitutes for Provanol | |
References
- PubChem. "propranolol". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).
- DrugBank. "propranolol". http://www.drugbank.ca/drugs/DB00571 (accessed September 17, 2018).
- MeSH. "Vasodilator Agents". https://www.ncbi.nlm.nih.gov/mesh/68... (accessed September 17, 2018).
Reviews
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Information checked by Dr. Sachin Kumar, MD Pharmacology
