• Sumial indications
• Uses of Sumial in details
• Sumial description
• Sumial dosage
• Sumial interactions
• Sumial side effects
• Sumial contraindications

What is Sumial?

Sumial 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.

Sumial is also used to treat severe chest pain (angina), migraine headaches, or hypertrophic subaortic stenosis (thickened heart muscle).

Sumial 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.

Sumial oral solution is used to treat proliferating infantile hemangioma.

Sumial 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.

Sumial is available only with your doctor's prescription.

Sumial indications

Hypertension

Sumial is indicated in the management of hypertension. It may be used alone or used in combination with other antihypertensive agents, particularly a thiazide diuretic. Sumial is not indicated in the management of hypertensive emergencies.

Angina Pectoris Due to Coronary Atherosclerosis

Sumial is indicated to decrease angina frequency and increase exercise tolerance in patients with angina pectoris.

Atrial Fibrillation

Sumial is indicated to control ventricular rate in patients with atrial fibrillation and a rapid ventricular response.

Myocardial Infarction

Sumial is indicated to reduce cardiovascular mortality in patients who have survived the acute phase of myocardial infarction and are clinically stable.

Migraine

Sumial is indicated for the prophylaxis of common migraine headache. The efficacy of Sumial in the treatment of a migraine attack that has started has not been established, and Sumial is not indicated for such use.

Essential Tremor

Sumial 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. Sumial causes a reduction in the tremor amplitude, but not in the tremor frequency. Sumial is not indicated for the treatment of tremor associated with Parkinsonism.

Hypertrophic Subaortic Stenosis

Sumial improves NYHA functional class in symptomatic patients with hypertrophic subaortic stenosis.

Pheochromocytoma

Sumial is indicated as an adjunct to alpha-adrenergic blockade to control blood pressure and reduce symptoms of catecholamine-secreting tumors.

How should I use Sumial?

Use Sumial solution as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Sumial 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 Sumial solution refilled.
• Do NOT shake Sumial solution before use.
• Use the syringe that comes with Sumial solution to measure the dose. Ask the pharmacist for help if you are unsure of how to measure the dose.
• Give Sumial solution right into your child's mouth. If needed, Sumial solution may be mixed in a small amount of milk or fruit juice and given in a baby's bottle.
• Give Sumial solution with or right after a feeding.
• Give doses of Sumial solution at least 9 hours apart.
• The dose of Sumial 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 Sumial solution on a regular schedule to get the most benefit from it. Giving Sumial 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 Sumial 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 Sumial solution.

Uses of Sumial 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 (Sumial): 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 Sumial 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 Sumial, is effective and recommended for primary and secondary prophylaxis of variceal hemorrhage.

Sumial description

A widely used non-cardioselective beta-adrenergic antagonist. R,S-Sumial 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.

Sumial dosage

Sumial Dosage

Generic name: Sumial 80mg

Dosage form: capsule, extended release

See also:

• Sumial Tablets
• Sumial capsule, extended release

The information at Drugs.com is not a substitute for medical advice. Always consult your doctor or pharmacist.

Sumial 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 Sumial (Sumial)

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Consumer resources

• Sumial
• Sumial (Advanced Reading)

• Other brands: Sumial, Sumial, InnoPran XL, Sumial

Professional resources

• Sumial (FDA)
• Sumial (AHFS Monograph)

Related treatment guides

• Atrial Fibrillation
• Ventricular Tachycardia

Sumial interactions

See also:
What other drugs will affect Sumial?

Patients receiving catecholamine-depleting drugs such as reserpine should be closely observed if Sumial 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 Sumial and haloperidol.

Aluminum hydroxide gel: Greatly reduces intestinal absorption of Sumial.

Ethanol: Slows the rate of absorption of Sumial.

Phenytoin, phenobarbitone: and rifampin accelerate Sumial clearance.

Chlorpromazine: When used concomitantly with Sumial, results in increased plasma levels of both drugs.

Antipyrine: and lidocaine have reduced clearance when used concomitantly with Sumial.

Thyroxine: May result in a lower than expected T₃ concentration when used concomitantly with Sumial.

Cimetidine Decreases the hepatic metabolism of Sumial, delaying elimination and incre:asing blood levels.

Theophylline: Clearance is reduced when used concomitantly with Sumial.

Sumial side effects

See also:
What are the possible side effects of Sumial?

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 Sumial in Infants with proliferating infantile hemangioma

In clinical trials for proliferating infantile hemangioma, the most frequently reported adverse reactions ( > 10%) in infants treated with Sumial 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 Sumial 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 Sumial than on placebo.

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 Sumial in a compassionate use program (CUP). Mean age at treatment initiation was 3.6 months. Mean dose of Sumial 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 Sumial. 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

Sumial contraindications

See also:
What is the most important information I should know about Sumial?

You should not use this medication if you are allergic to Sumial, 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 Sumial. You may need to stop using the medicine for a short time.

Do not skip doses or stop using Sumial 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 Sumial.

Sumial 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 Sumial:

Propranolol in Spain.

Propranolol hydrochloride in Spain.

References

1. PubChem. "propranolol". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).
2. DrugBank. "propranolol". http://www.drugbank.ca/drugs/DB00571 (accessed September 17, 2018).
3. MeSH. "Vasodilator Agents". https://www.ncbi.nlm.nih.gov/mesh/68... (accessed September 17, 2018).

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Information checked by Dr. Sachin Kumar, MD Pharmacology