Sintaser Uses

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What is Sintaser?

Sintaser 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.

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

Sintaser 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.

Sintaser oral solution is used to treat proliferating infantile hemangioma.

Sintaser 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.

Sintaser is available only with your doctor's prescription.

Sintaser indications

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Hypertension

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

Angina Pectoris Due to Coronary Atherosclerosis

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

Atrial Fibrillation

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

Myocardial Infarction

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

Migraine

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

Essential Tremor

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

Hypertrophic Subaortic Stenosis

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

Pheochromocytoma

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

How should I use Sintaser?

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

Ask your health care provider any questions you may have about how to use Sintaser solution.

Uses of Sintaser in details

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

Sintaser description

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

Sintaser dosage

Sintaser Dosage

Generic name: Sintaser HYDROCHLORIDE 80mg

Dosage form: capsule, extended release

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

Sintaser 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 Sintaser (Sintaser)

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Sintaser interactions

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What other drugs will affect Sintaser?

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

Aluminum hydroxide gel: Greatly reduces intestinal absorption of Sintaser.

Ethanol: Slows the rate of absorption of Sintaser.

Phenytoin, phenobarbitone: and rifampin accelerate Sintaser clearance.

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

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

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

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

Theophylline: Clearance is reduced when used concomitantly with Sintaser.

Sintaser side effects

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What are the possible side effects of Sintaser?

The following serious adverse reactions are discussed in greater detail in other sections of the labeling:

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 Sintaser in Infants with proliferating infantile hemangioma

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

Reaction Placebo

N=236

Sintaser 1.2 mg/kg/day

N=200

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

Sintaser contraindications

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What is the most important information I should know about Sintaser?

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

Do not skip doses or stop using Sintaser 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 Sintaser.

Sintaser 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 Sintaser:

Propranolol in Mexico.


List of Sintaser substitutes (brand and generic names)

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Unit description / dosage (Manufacturer)Price, USD
Sinlihaul 40 mg x Blister pk
Siron Plus Propranolol hydrochloride 20mg, Alprazolam 0.25 mg. TAB / 10 (Gujarat Terce)$ 0.17
SIRON PLUS 0.25MG/20MG TABLET 1 strip / 10 tablets each (Gujarat Terce)$ 0.16
SIRON PLUS tab 10's (Gujarat Terce)$ 0.29
Siron Plus 0.25 mg/20 mg Tablet (Gujarat Terce)$ 0.02
Capsule; Oral; Propranolol Hydrochloride 160 mg (Abic)
Capsule; Oral; Propranolol Hydrochloride 80 mg (Abic)
Capsules; Oral; Propranolol Hydrochloride 160 mg (Abic)
Capsules; Oral; Propranolol Hydrochloride 80 mg (Abic)
Capsule, Prolonged Release; Oral; Propranolol Hydrochloride 80 mg
Capsules, Prolonged Release; Oral; Propranolol Hydrochloride 80 mg
Capsule, Prolonged Release; Oral; Propranolol Hydrochloride 80 mg
Capsules, Prolonged Release; Oral; Propranolol Hydrochloride 80 mg
Sudenol 10 mg
Injectable; Injection; Propranolol Hydrochloride 0.1% (Icaro)
Suspension; Oral; Propranolol Hydrochloride 10 mg / ml (Icaro)
Tablet; Oral; Propranolol Hydrochloride 10 mg (Icaro)
Tablet; Oral; Propranolol Hydrochloride 20 mg (Icaro)
Tablet; Oral; Propranolol Hydrochloride 40 mg (Icaro)
Tablet; Oral; Propranolol Hydrochloride 60 mg (Icaro)
Tablet; Oral; Propranolol Hydrochloride 80 mg (Icaro)
Tablet; Oral; Propranolol Hydrochloride 90 mg (Icaro)
Tablets; Oral; Propranolol Hydrochloride 10 mg (Icaro)
Tablets; Oral; Propranolol Hydrochloride 20 mg (Icaro)
Tablets; Oral; Propranolol Hydrochloride 40 mg (Icaro)
Tablets; Oral; Propranolol Hydrochloride 60 mg (Icaro)
Tablets; Oral; Propranolol Hydrochloride 80 mg (Icaro)
Tablets; Oral; Propranolol Hydrochloride 90 mg (Icaro)
Capsule, Prolonged Release; Oral; Propranolol Hydrochloride 160 mg
Capsule, Prolonged Release; Oral; Propranolol Hydrochloride 80 mg
Capsules, Prolonged Release; Oral; Propranolol Hydrochloride 160 mg
Capsules, Prolonged Release; Oral; Propranolol Hydrochloride 80 mg
Susin 20 mg
Susin 40 mg
Syntonol 10 10 mg x 1, 000's (Codal synto)
Syntonol 40 40 mg x 1, 000's (Codal synto)

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

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